(52 days)
No reference devices were used in this submission.
No
The 510(k) summary describes a standard electrosurgical bipolar forceps for coagulation and irrigation. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of such capabilities. The performance testing focuses on equivalence to a predicate device based on materials and intended use, not on algorithmic performance.
Yes.
The device is used for bipolar coagulation and irrigation of tissue, which are therapeutic interventions in surgery.
No
Explanation: The device is described as a surgical tool used for bipolar coagulation and irrigation of tissue, not for diagnosing conditions. Its function involves grasping, manipulating, coagulating, and irrigating soft tissues during open surgery, which are therapeutic actions rather than diagnostic ones.
No
The device description clearly describes physical forceps with preattached cables, intended for grasping, manipulating, coagulating, and irrigating tissue. It is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "bipolar coagulation and irrigation of tissue for general open surgery where coagulation of soft tissue is needed." This describes a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The description details how the forceps grasp, manipulate, coagulate, and irrigate soft tissues during surgery. This aligns with a surgical instrument, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are intended for use by a physician familiar with electrosurgery for bipolar coagulation and irrigation of tissue for general open surgery where coagulation of soft tissue is needed. Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must be operated within the following parameters:
-Frequency range between 300 kHz-1,000 kHZ;
-Maximum generator operating voltage 600Vp.
Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. The types of surgery intended include:
-ENT
-Gynecology
-Urology
-General Surgery
-Neurosurgery
-Laryngeal Surgery
-Orthopedic Surgery
-Thoracic Surgery
Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must only be used with a bipolar coagulation current.
HG Innovations, as a manufacturer, does not recommend a specific procedure.
Use of bipolar techniques may be desirable in order to avoid unwanted tissue damage for surgical procedures where HF current could flow through relatively small cross-sectional area of body.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The single-use, non-stick bipolar forceps and single-use, non-stick irrigating bipolar forceps (various sizes, designs and tip configurations), with preattached cables are designed to grasp, manipulate, coagulate and irrigate soft tissues and are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. The blood vessel or tissue is grasped between the forceps tines, each of which acts as an electrode, and current passes to desiccate and coagulate the tissue. Bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coaqulation current. The bipolar forceps must be operated with the following parameters:
-Frequency range between 300 kHz-1,000 kHZ: -Maximum generator operating voltage 600Vp.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician familiar with electrosurgery, general open surgery
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Performance Testing: System Testing - HG Innovation's bipolar forceps are identical to the predicate device in their intended use/indications for use and materials used for the arms, and tips. No further testing necessary.
Software Verification and Validation Testing - N/A
Mechanical and acoustic Testing - N/A
Animal Study - N/A
Human Clinical Performance Testing - N/A
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 20, 2023
HG Innovations Ltd % Wondwossem Tekolla Associate Regulatory Consultant Medical Device Academy 345 Lincoln Hill Road Shrewsbury, Vermont 05738
Re: K233351
Trade/Device Name: Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cable (HNSAG-1115J); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 1.0mm Tip with Cable (HNSAG-1120A); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 0.5mm Tip with Cable (HNSAG-5120A); Single Use Non-Stick Adson Bipolar Forceps, 150mm, 1.0mm Tip with Cable (HNSAG-1150A); Single Use Non-Stick Straight Bipolar Forceps, 150mm, 0.5mm Tip with Cable (HNSAG-5150S); Single Use Non-Stick Straight Bipolar Forceps, 150mm, 1.0mm Tip with Cable (HNSAG-1150S); Single Use Non-Stick Straight Bipolar Forceps, 160mm, 0.5mm Tip with Cable (HNSAG-5160S); Single Use Non-Stick Straight Bipolar Forceps, 160mm, 1.0mm Tip with Cable (HNSAG-1160S); Single Use Non-Stick Straight Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HNSAG-5180S); Single Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 29, 2023 Received: September 29, 2023
Dear Wondwossem Tekolla:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some
1
cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
2
the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.11.20
13:04:01 -05'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Irrigation Tubing (HNSAG-2220S/IRS);
K233351
Device Name
Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M): Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cable (HNSAG-1115J); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 1.0mm Tip with Cable (HNSAG-1120A); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 0.5mm Tip with Cable (HNSAG-5120A); Single Use Non-Stick Adson Bipolar Forceps, 150mm, 1.0mm Tip with Cable (HNSAG-1150A); Single Use Non-Stick Straight Bipolar Forceps, 150mm, 0.5mm Tip with Cable (HNSAG-5150S); Single Use Non-Stick Straight Bipolar Forceps, 150mm, 1.0mm Tip with Cable (HNSAG-1150S); Single Use Non-Stick Straight Bipolar Forceps, 160mm, 0.5mm Tip with Cable (HNSAG-5160S); Single Use Non-Stick Straight Bipolar Forceps, 160mm, 1.0mm Tip with Cable (HNSAG-1160S); Single Use Non-Stick Straight Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HNSAG-5180S); Single Use Non-Stick Straight Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HNSAG-1180S); Single Use Non-Stick Straight Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HNSAG-1200S); Single Use Non-Stick Straight Bipolar Forceps, 200mm, Angled 1.0mm Tip with Cable (HNSAG-1200SA): Single Use Non-Stick Bayonet Bipolar Forceps, 165mm, 1.0mm Tip with Cable (HNSAG-1165B); Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HNSAG-1200B); Single Use Non-Stick Bayonet Bipolar Forceps, 220mm, 1.0mm Tip with Cable (HNSAG-1220B); Single Use Non-Stick Bayonet Bipolar Forceps, 240mm, 1.0mm Tip with Cable (HNSAG-1240B); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 150mm, 0.5mm Tip with Cable & Irrigation Tubing (HNSAG-5150S/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 150mm, 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1150S/IRS): Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 160mm, 0.5mm Tip with Cable & Irrigation Tubing (HNSAG-5160S/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 160mm, 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1160S/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 180mm, 0.5mm Tip with Cable & Irrigation Tubing (HNSAG-5180S/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 180mm, 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1180S/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 200mm, 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1200S/IRS): Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 200mm, 2.0mm Tip with Cable & Irrigation Tubing (HNSAG-2200S/IRS): Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 200mm, Angled 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1200SA/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 200mm, Angled 2.0mm Tip with Cable & Irrigation Tubing (HNSAG-2200SA/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 220mm, 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1220S/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 220mm, 2.0mm Tip with Cable &
4
Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 220mm, Angled 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1220SA/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 220mm, Angled 2.0mm Tip with Cable & Irrigation Tubing (HNSAG-2220SA/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 240mm, 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1240S/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 240mm, 2.0mm Tip with Cable & Irrigation Tubing (HNSAG-2240S/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 240mm, Angled 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1240SA/IRS); Single Use Non-Stick, Irrigating, Straight Bipolar Forceps, 240mm, Angled 2.0mm Tip with Cable & Irrigation Tubing (HNSAG-2240SA/IRS); Single Use Non-Stick, Irrigating, Bayonet Bipolar Forceps, 165mm, 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1165B/IRS): Single Use Non-Stick, Irrigating, Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1200B/IRS): Single Use Non-Stick, Irrigating, Bayonet Bipolar Forceps, 220mm, 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1220B/IRS); Single Use Non-Stick, Irrigating, Bayonet Bipolar Forceps, 240mm, 1.0mm Tip with Cable & Irrigation Tubing (HNSAG-1240B/IRS) ndications for Use (Describe)
McPherson Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are intended for use by a physician familiar with electrosurgery for bipolar coagulation and irrigation of tissue for general open surgery where coagulation of soft tissue is needed. Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must be operated within the following parameters:
-Frequency range between 300 kHz-1,000 kHZ;
-Maximum generator operating voltage 600Vp.
Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. The types of surgery intended include:
-ENT
-Gynecology
- -Urology
- -General Surgery
- -Neurosurgery
- -Laryngeal Surgery
- -Orthopedic Surgery
- -Thoracic Surgery
Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must only be used with a bipolar coagulation current.
HG Innovations, as a manufacturer, does not recommend a specific procedure.
Use of bipolar techniques may be desirable in order to avoid unwanted tissue damage for surgical procedures where HF current could flow through relatively small cross-sectional area of body.
5
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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6
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
| SUBMITTER: | Mr. Wondwossen Tekolla |
|---|---|
| Company Name: | Medical Device Academy Inc. |
| Address: | 345 Lincoln Hill Rd |
| City, State, Zip USA | Shrewsbury, VT 05738 |
| Tel: | 919-903-0194 |
| Fax: | N/A |
| Contact Person: | Dr. M Umran Rafiq |
|---|---|
| Date Prepared: | August 23, 2023 |
DEVICE ll.
| Device Trade Name: | Heinrich Single Use Non-Stick Bipolar Forceps/ Heinrich
Single Use Irrigating Non-Stick Bipolar Forceps |
|------------------------------|------------------------------------------------------------------------------------------------------------|
| Classification Name: | Electrosurgical Cutting & Coagulation Device and
Accessories |
| Requlation: | 21 CFR §878.4400 |
| Regulatory Class: | Class II |
| Device Panel: | General & Plastic Surgery |
| Product Classification Code: | GEI |
PREDICATE DEVICE lll.
| A) Predicate 1: Irrigating forceps. | |
|---|---|
| Predicate Manufacturer: | Adeor Medical AG |
| Predicate Trade Name: | Adeor Medical nxt™ Non-stick Bipolar Forceps |
| Adeor Medical nxt™ Single-Use Non-stick Bipolar Forceps | |
| Predicate 510(k): | K191847 |
B) Predicate 2: Non-irrigating forceps
| Predicate Manufacturer: | Faulhaber by Pinzetten OHG |
|---|---|
| Predicate Trade Name: | Single Use Non-Stick Bipolar Forceps sterile/non sterile, |
| Single Use Non-Stick Bipolar Irrigating Forceps sterile/ non | |
| sterile | |
| Predicate 510(k): | K182773 |
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The single-use, non-stick bipolar forceps and single-use, non-stick irrigating bipolar forceps (various sizes, designs and tip configurations), with preattached cables are designed to grasp, manipulate, coagulate and irrigate soft tissues and are intended for
7
use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. The blood vessel or tissue is grasped between the forceps tines, each of which acts as an electrode, and current passes to desiccate and coagulate the tissue. Bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coaqulation current. The bipolar forceps must be operated with the following parameters:
-Frequency range between 300 kHz-1,000 kHZ: -Maximum generator operating voltage 600Vp.
V. INDICATIONS FOR USE
Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are intended for use by a physician familiar with electrosurgery for bipolar coagulation and irrigation of tissue for general open surgery where coagulation of soft tissue is needed. Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must be operated within the following parameters:
-Frequency range between 300 kHz-1,000 kHZ;
-Maximum generator operating voltage 600Vp.
Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. The types of surgery intended include:
-ENT
- -Gynecology
- -Urology
- -General Surgery
- -Neurosurgery
- -Laryngeal Surgery
- -Orthopedic Surgery
- -Thoracic Surgery
Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must only be used with a bipolar coagulation current.
HG Innovations, as a manufacturer, does not recommend a specific procedure.
Use of bipolar techniques may be desirable in order to avoid unwanted tissue damage for surgical procedures where HF current could flow through relatively small crosssectional area of body.
8
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE & PERFORMANCE DATA
Table 1: Comparison of subject device, Heinrich Single Use Non-Stick Bipolar Forceps with Cable – and Predicate Device, Adeor Medical nxt™ Non-stick Bipolar Forceps Adeor Medical nxt™ Single-Use Non-stick Bipolar Forceps- K191847
| Feature | Subject Device | Predicate Device | Justification For
Differences |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Heinrich Single Use
Non-Stick Bipolar
Forceps with Cable –
(Multiple models with
different sizes) | Adeor Medical nxt™
Non-stick Bipolar
Forceps/ Adeor
Medical nxt™
Single-Use Non-
stick Bipolar
Forceps K191847 | |
| Manufacturer | HG Innovations Ltd. | Adeor Medical AG | ---------- |
| Regulation | 878.4400 | 878.4400 | Same |
| Classification 21 | Class II | Class II | Same |
| Product Code | GEI | GEI | Same |
| Device Description | The product family
“Single Use Bipolar
Forceps”, including
Heinrich Single Use,
Non-Stick Bipolar
Forceps (various
sizes, designs and tip
configurations), with
Pre-Attached Cable
are designed to
grasp, manipulate,
coagulate and irrigate
soft tissues and are
intended for use by a
physician familiar with
electrosurgery in
bipolar coagulation
for general open
surgery where
coagulation of soft
tissue is needed. The
blood vessel or tissue
is grasped between
the forceps tines,
each of which acts as
an electrode, and
current passes to
desiccate and
coagulate the tissue.
Bipolar forceps are
coppected through a | The Adeor Medical
AG Bipolar Forceps
are electrosurgical
instruments used to
grasp, manipulate,
cut or
coagulate tissue.
Bipolar forceps have
various lengths and
tip configurations, as
well as irrigation and
suction
technologies. Both
reusable and single-
use forceps are
available, with flat
plug or two pin plug
configurations.
Bipolar forceps are
connected through a
suitable bipolar
cable with the
bipolar output of a
high frequency
generator and may
be used only with
bipolar coagulation
current. Adeor
bipolar forceps
must be operated
with the following | Similar |
| | | | |
| suitable bipolar cable
with the bipolar output
of an electrosurgical
generator. Bipolar
forceps must only be
used with bipolar
coagulation current.
The Single Use, Non-
Stick Bipolar Forceps
are single use
products and must
not be reused. | parameters:
Frequency range
between 300 kHz
and 1,000 kHz:
maximum generator
operating voltage
600Vp. | | |
| Indications for use | | | |
| Heinrich Single-use
non-stick bipolar
forceps are intended
for use by a physician
familiar with
electrosurgery for
bipolar coagulation
and irrigation of tissue
for general open
surgery where
coagulation of soft
tissue is needed.
Single-use non-stick
bipolar forceps must
be operated within
the following
parameters:
-Frequency range
between 300 kHz-
1,000 kHZ;
-Maximum generator
operating voltage
600Vp.
Single-use non-stick
bipolar forceps have
not been shown to be
effective for tubal
sterilization or tubal
coagulation for
sterilization
procedures and
should not be used
for these procedures.
The types of surgery
intended include: | The Adeor Medical
Non-stick Bipolar
Forceps are
intended for use by
a physician familiar
with
electrosurgery in
bipolar coagulation
for general open
surgery where
coagulation of soft
tissue is
needed. Adeor
bipolar forceps must
be operated with the
following
parameters:
Frequency range
between 300 kHz
and 1,000 kHZ;
maximum generator
operating voltage
600Vp.
The Adeor Medical
Non-stick Bipolar
Forceps have not
been shown to be
effective for tubal
sterilization or tubal
coagulation for
sterilization
procedures and
should not be used
for these
procedures.
The types of surgery | Same | |
| | -ENT
-Gynecology
-Urology
-General Surgery
-Neurosurgery
-Laryngeal Surgery
-Orthopedic Surgery
-Thoracic Surgery
Single-use non-stick
bipolar forceps and
are connected
through a suitable
bipolar cable with the
bipolar output of an
electrosurgical
generator. Single-use
non-stick bipolar
forceps must only be
used with a bipolar
coagulation current.
HG Innovations, as a
manufacturer, does
not recommend a
specific procedure.
Use of bipolar
techniques may be
desirable in order to
avoid unwanted
tissue damage for
surgical procedures
where HF current
could flow through
relatively small cross-
sectional area of
body. - Thoracic
Surgery | -ENT
-Gynecology (except
for use in female
sterilization)
-Urology
-General Surgery
-Neurosurgery
-Laryngeal Surgery
-Orthopedic Surgery
-Thoracic Surgery | |
| Rx/ OTC | Rx | Rx | Same |
| Design | Bayonet | Bayonet | Same |
| | Mcpherson | N/A | N/A |
| | Jeweller | N/A | N/A |
| | Adson | N/A | N/A |
| | Straight | N/A | N/A |
| | Irrigating Bayonet | N/A | N/A |
| | Irrigating Straight | N/A | N/A |
| Energy Source | Generator | Generator | Same |
| Single Use | Yes | Both single use and
multiuse | Subject device is
single use,
predicate device
has both single use
and multiuse
devices. Disposable
use of subject
device reduces risk. |
| Maximum Peak Voltage | 600 Vp | 600Vp | Same |
| Electrode Type | Bipolar | Bipolar | Same |
| Tip Sizes | 0.5mm-1.5mm | 0.2mm-1.5mm | Range of tip sizes
for predicate device
completely overlap
that of the subject
device. Larger tip
will decrease
current density and
last longer than
smaller tips. |
| Lengths | 110mm-240mm | 127mm-254mm | Range of lengths is
similar and largely
overlaps with
predicate device. |
| Component Materials | | | |
| Forceps' Tip(s) | Ag800 (80% pure
silver) | Ag800 (80% pure
silver) | Forceps tip
materials are
identical for the
intended use of the
single-use subject
device |
| Arm Material | Stainless steel AISI
420 | Stainless Steel | Forceps arm
materials are
identical |
| Outer Cap | Polypropylene,
SABIC® PP
107M90T + Master
Colour, Black | N/A | N/A |
| Cable | Polyvinyl Cholride
(PVC), 2/16 core,
Copper Wires | N/A | Both are made of
plastic |
| Solder | Tin | N/A | N/A |
| Powder Coating | Nylon Powder,
Polyamide 11 | Polyamide | Both are made of
plastic and are non
patient contacting |
| Colorant | Pigment Blue 15:3
UN8632 | N/A | N/A |
| Forging Blank | Stainless steel AISI
420 | N/A | N/A |
| Inner Cap | Polypropylene,
SABIC® PP
107M90T + Master
Colour, Black | N/A | N/A |
| Banana Pin | Chrome-plated, Gold
plated spring, Brass | N/A | N/A |
| Internal Plug Body | Polypropylene,
SABIC® PP
107M90T + Master
Colour, Black | N/A | N/A |
| Outer Plug Body | Polyvinyl Chloride
(PVC) | N/A | Both are made of
plastic |
| Sterility Testing (ISO-
10993-7) | Ethylene Oxide (EO) | Gamma Irradiation/
Steam | Both are recognized
sterility methods. |
| Shelf-Life Testing | Real-time aging study
shows product shelf
life up to 3 years | N/A | N/A |
| Packaging | Paper/Film Pouch
Tyvek/Film Pouch | PETG Tray/ Tyvek
lid | Similar |
| Performance Testing | | | |
| Biocompatibility
(ISO10993-1)
Cytotoxicity (ISO-
10993-5)
Irritation (ISO-10993-10
Sensitization (ISO-
10993-10)
Pyrogenicity (USP151)
Systemic Toxicity (ISO-
10993-11) | Pass | N/A | Subject devices is
demonstrably non-
cytotoxic, non-
irritating,
systemically non
toxic, non-
sensitizing and
passes pyrogenicity
testing. Predicate
device has not
reported
biocompatibility
testing. |
| Electrical Safety &
EMC (AAMI/ANSI IEC
60601-1, IEC 60601-2-
2) | | | |
| High-frequency leakage
current | Pass | Pass | Same |
| High-frequency
dielectric strength | Pass | Pass | Same |
| Mains frequency
dielectric strength | Pass | Pass | Same |
| Mechanical Testing | Pass | Pass | Same |
9
10
11
12
13
Table 1: Comparison of subject device, Heinrich Single Use Non-Stick Irrigating Bipolar Forceps with Cable, and Predicate Device, Faulhaber Single Use Non-Stick Bipolar Forceps sterile/non sterile, Single Use Non-Stick Bipolar Irrigating Forceps sterile/ non sterile-K182773
| Feature | Subject Device | Predicate Device | Justification For Differences |
|---|---|---|---|
| Heinrich Single Use | |||
| Non-Stick Irrigating | |||
| Bipolar Forceps with | |||
| Cable | |||
| (Multiple models with | |||
| different sizes) | Single Use Non- | ||
| Stick Bipolar | |||
| Forceps sterile/non | |||
| sterile, | |||
| Single Use Non- | |||
| Stick Bipolar | |||
| Irrigating Forceps | |||
| sterile/ non sterile- | |||
| K182773 | |||
| Manufacturer | HG Innovations Ltd. | Faulhaber by | |
| Pinzetten OHG | |||
| Regulation | 878.4400 | 878.4400 | |
| Classification 21 | Class II | Class II | |
| Product Code | GEI | GEI | |
| Device Description | The product family | ||
| "Single Use Bipolar | |||
| Forceps", including | |||
| Heinrich Single Use, | |||
| Non-Stick Irrigating | |||
| Bipolar Forceps | |||
| (various sizes, | |||
| designs and tip | |||
| configurations), with | |||
| Pre-Attached Cables | |||
| are designed to | |||
| grasp, manipulate, | |||
| coagulate and irrigate | |||
| soft tissues and are | |||
| intended for use by a | |||
| physician familiar with | |||
| electrosurgery in | |||
| bipolar coagulation | |||
| for general open | |||
| surgery where | |||
| coagulation of soft | |||
| tissue is needed. The | |||
| blood vessel or tissue | |||
| is grasped between | |||
| the forceps tines | The product family | ||
| "Single Use Bipolar | |||
| Forceps", including | |||
| Faulhaber Single | |||
| Use Non-Stick | |||
| Bipolar Forceps and | |||
| Single Use Non- | |||
| Stick Bipolar | |||
| Irrigating Forceps, | |||
| are intended to be | |||
| used for bipolar | |||
| coagulation and | |||
| irrigation of tissue by | |||
| physicians familiar | |||
| with bipolar | |||
| coagulation in | |||
| medical practices | |||
| and clinics. | |||
| The Single Use | |||
| Bipolar Forceps are | |||
| single use products | |||
| and must not be | |||
| reused. They are | |||
| provided sterile as | |||
| well as non-sterile |
14
| each of which acts as
an electrode, and
current passes to
desiccate and
coagulate the tissue.
Bipolar forceps are
connected through a
suitable bipolar cable
with the bipolar output
of an electrosurgical
generator. Bipolar
forceps must only be
used with bipolar
coagulation current.
The Single Use, Non-
Stick Bipolar Irrigating
Forceps are single
use products and
must not be reused.
The Single Use, Non-
Stick Bipolar Irrigating
Forceps are with
irrigation function.
The irrigation function
works via a drain
running along the
forceps tines from tip
to handle. At handle
height, the drain is
connected by Luer-
Lock via an irrigation
tubing with an
irrigation pump. | Products delivered
non sterile must be
cleaned,
disinfected and
sterilized before use.
For the application
the Single Use
Bipolar Forceps
have to be
connected by
appropriate
bipolar cable to the
bipolar output of an
HF generator.
Bipolar cables and
ESU are not part
of the subject
device.
The Single Use
Bipolar Forceps are
provided in bayonet
design with non-
stick tips and are
identical in design,
construction,
materials and
manufacturing to the
reusable device
EGON
FAULHABER
Bipolar Non-Stick
Forceps (K101080).
The principles of
operation and
mechanism of action
are identical as well.
In addition to the
cleared and legally
marketed EGON
FAULHABER
devices, the
products
are with irrigation
function available.
The irrigation
function works via a
drain running along
the forceps tines
from tip to handle. At
The principles of
operation and
mechanism of action
are identical as well. |
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
15
| Indications for use | |||
|---|---|---|---|
| Heinrich single-use | |||
| non-stick irrigating | |||
| bipolar forceps are | |||
| intended for use by a | |||
| physician familiar with | |||
| electrosurgery for | |||
| bipolar coagulation | |||
| and irrigation of tissue | |||
| for general open | |||
| surgery where | |||
| coagulation of soft | |||
| tissue is needed. | |||
| Single-use non-stick | |||
| irrigating bipolar | |||
| forceps must be | |||
| operated within the | |||
| following parameters: | |||
| -Frequency range | |||
| between 300 kHz- | |||
| 1,000 kHZ; | |||
| -Maximum generator | |||
| operating voltage | |||
| 600Vp. |
Single-use non-stick
irrigating bipolar
forceps have not
been shown to be
effective for tubal
sterilization or tubal
coagulation for
sterilization
procedures and
should not be used
for these procedures.
The types of surgery
intended include:
-ENT
-Gynecology
-Urology
-General Surgery | handle height, the
drain is connected
by Luer-Lock
via an irrigation
tubing with an
irrigation pump.
Faulhaber Single
Use Non-Stick
Bipolar Forceps
sterile/ non-sterile
and Single Use Non-
Stick Irrigating
Forceps sterile/ non-
sterile are intended
for use by a
physician familiar
with
electrosurgery for
bipolar coagulation
and irrigation of
tissue for general
surgery. The
bipolar forceps are
used with the bipolar
output for standard
electrosurgical
generators.
The products are
intended for single
use and are
provided sterile as
well as non sterile.
Products supplied
non sterile must be
cleaned, disinfected
and sterilized prior
to their use
by the validated
cleaning,
disinfection and
sterilization process.
The bipolar forceps
have not been
shown to be
effective for tubal
sterilization or tubal
coagulation for
sterilization | Same | |
| | | | |
| | -Laryngeal Surgery
-Orthopedic Surgery
-Thoracic Surgery
Single-use non-stick
irrigating bipolar
forceps are
connected through a
suitable bipolar cable
with the bipolar output
of an electrosurgical
generator. Single-use
non-stick irrigating
bipolar forceps must
only be used with a
bipolar coagulation
current.
HG Innovations, as a
manufacturer, does
not recommend a
specific procedure.
Use of bipolar
techniques may be
desirable in order to
avoid unwanted
tissue damage for
surgical procedures
where HF current
could flow through
relatively small cross-
sectional area of
body. | should not be used
for these
procedures.
The types of surgery
intended are
- General surgery
- Laryngeal
coagulation - Orthopedic
coagulation - Thoracic
coagulation - Neurosurgical
coagulation - Gynecological
coagulation (except
for use in female
sterilization) - Urological
coagulation - Ear-, Nose- and
Throat coagulation | |
| Rx/ OTC | Rx | Rx | Same |
| Design | Bayonet | Bayonet | Same |
| | Straight | N/A | N/A |
| | | N/A | N/A |
| | | N/A | N/A |
| Irrigation feature | Yes | Yes | Same |
| Energy Source | Generator | Generator | Same |
| Single Use | Yes | Yes | Same. Disposable
use of subject
device reduces risk. |
| Maximum Peak Voltage | 600 Vp | Sterile : Cleerpeel®
Foil Pouch
Non-sterile : foil bag
with cardboard box | Different. Packaging
difference does not
affect safety of
subject device. |
| Performance Testing | | | |
| Biocompatibility
(ISO10993-1)
Cytotoxicity (ISO-
10993-5)
Irritation (ISO-10993-10
Sensitization (ISO-
10993-10)
Pyrogenicity (USP151)
Systemic Toxicity (ISO-
10993-11) | Pass | pass | Subject devices is
demonstrably non-
cytotoxic, non-
irritating,
systemically non
toxic, non-
sensitizing and
passes pyrogenicity
testing. Predicate
device has not
reported
biocompatibility
testing. |
| Electrical Safety &
EMC (AAMI/ANSI IEC
60601-1, IEC 60601-2-
-
| | | |
| High-frequency leakage
current | Pass | Pass | Same |
| High-frequency | Pass | Pass | Same |
| Mains frequency
dielectric strength | Pass | Pass | Same |
| Active Accessory
Insulation | Pass | Pass | Same |
| Mechanical Testing | Pass | Pass | Same |
| Drop Test | N/A | Pass | N/A |
16
17
18
19
Bench Performance Testing System Testing
HG Innovation's bipolar forceps are identical to the predicate device in their intended use/indications for use and materials used for the arms, and tips. No further testing necessary.
Software Verification and Validation Testing N/A
Mechanical and acoustic Testing N/A
Animal Study
N/A
Human Clinical Performance Testing N/A
VII. CONCLUSION
Based on the indications for use, technological characteristics and comparison with the predicate devices, the subject devices have demonstrated substantial equivalence.