(52 days)
No reference devices were used in this submission.
No
The description focuses on the electrosurgical function and physical characteristics of the forceps, with no mention of AI or ML.
Yes
Explanation: The device is intended for "bipolar coagulation and irrigation of tissue for general open surgery where coagulation of soft tissue is needed," which are therapeutic actions.
No
Explanation: The device is described as "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." This indicates a therapeutic or surgical function (coagulation and irrigation of tissue) rather than a diagnostic one.
No
The device is described as bipolar forceps, which are physical instruments used in surgery. The summary explicitly mentions materials used for arms and tips and bench performance testing, indicating a hardware component. Software verification and validation testing is listed as "N/A".
Based on the provided text, the Heinrich Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The intended use and device description clearly state that these forceps are used in vivo (inside the body) during surgical procedures for bipolar coagulation and irrigation of soft tissue. They are directly applied to the tissue within the patient's body.
Therefore, these forceps are surgical instruments used for therapeutic and procedural purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Heinrich 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. Heinrich Single-use nonstick 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. Heinrich Single-use non-stick bipolar forceps and Heinrich 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 Heinrich Single-use non-stick bipolar forceps and Heinrich single-use non-stick irrigating bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Heinrich single-use non-stick bipolar forceps and Heinrich 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
HG Innovations Ltd.'s electrical surgical instruments encompass a wide variety of instruments that are widely used in the medical industry. Electrosurgical forceps and electrodes have been used in surgery for many years. The single-use, non-stick bipolar forceps and non-stick bipolar irrigating forceps (various sizes 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 / 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: 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 % Wondwossen Tekolla Associate Regulatory Consultant Medical Device Academy, Inc 345 Lincoln Hill Road Shrewsbury, Vermont 05738
Re: K233346
Trade/Device Name: Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.5mm Tip with Cable (HMAL20/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 230mm, 0.5mm Tip with Cable (HMAL23/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 230mm, 1.0mm Tip with Cable (HMAL23/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 230mm, 1.5mm Tip with Cable (HMAL23/015); Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable & Irrigation Tubing (H Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 15, 2023 Received: September 29, 2023
Dear Wondwossen 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 (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
provisions of the Act. Although this letter refers to your product as a device, please be aware that some 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 OS 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 (QS) 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
2
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See 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,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.11.20 13:08:27 -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)
| Submission Number (if known) | K233346 |
|---|---|
| Device Name | Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); |
| Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); | |
| Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); | |
| Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); | |
| Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010); | |
| Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.5mm Tip with Cable (HMAL20/015); | |
| Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 230mm, 0.5mm Tip with Cable (HMAL23/005); | |
| Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 230mm, 1.0mm Tip with Cable (HMAL23/010); | |
| Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 230mm, 1.5mm Tip with Cable (HMAL23/015); | |
| Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable & Irrigation Tubing (HMAL18/005/IRD); | |
| Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable & Irrigation Tubing (HMAL18/010/IRD); | |
| Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable & Irrigation Tubing (HMAL18/015/IRD); | |
| Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable & Irrigation Tubing (HMAL20/005/IRD); | |
| Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable & Irrigation Tubing (HMAL20/010/IRD); | |
| Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 200mm, 1.5mm Tip with Cable & Irrigation Tubing (HMAL20/015/IRD); | |
| Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 230mm, 0.5mm Tip with Cable & Irrigation Tubing (HMAL23/005/IRD); | |
| Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 230mm, 1.0mm Tip with Cable & Irrigation Tubing (HMAL23/010/IRD); | |
| Heinrich Single Use Non-Stick, Irrigating Bayonet Bipolar Forceps, 230mm, 1.5mm Tip with Cable & Irrigation Tubing (HMAL23/015/IRD) | |
| Indications for Use (Describe) | Heinrich 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. Heinrich Single-use nonstick 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.
4
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
e-Counter Use (21 CFR 801 Subpart C)
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5
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
| I. 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 |
| Regulation: | 21 CFR §878.4400 |
| Regulatory Class: | Class II |
| Device Panel: | General & Plastic Surgery |
| Product Classification Code: | GEI |
lll. PREDICATE DEVICE
| A) Predicate 1: Irrigating forceps. | |
|---|---|
| Predicate Manufacturer: | Synergetics, Inc. |
| Predicate Trade Name: | Synergetics Disposable Single Use Dual Irrigating Standard |
| Bipolar Forceps | |
| Predicate 510(k): | K110924 |
| B) Predicate 2: Non-irrigating forceps | |
| Predicate Manufacturer: | Sutter Medizintechnik GmbH |
| Predicate Trade Name: | Sutter Swyng® Nonstick Bipolar Forceps- Single Use |
| Predicate 510(k): | K193587 |
No reference devices were used in this submission.
DEVICE DESCRIPTION IV.
HG Innovations Ltd.'s electrical surgical instruments encompass a wide variety of instruments that are widely used in the medical industry. Electrosurgical forceps and electrodes have been used in surgery for many years. The single-use, non-stick bipolar forceps and non-stick bipolar irrigating forceps (various sizes and tip configurations), with preattached cables are designed to grasp, manipulate, coagulate and irrigate soft
6
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.
V. INDICATIONS FOR USE
Heinrich single-use non-stick bipolar forceps and 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. Heinrich single-use non-stick bipolar forceps and Heinrich singleuse 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.
Heinrich Single-use non-stick bipolar forceps and Heinrich 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
Heinrich Single-use non-stick bipolar forceps and Heinrich single-use non-stick irrigating bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Heinrich single-use non-stick bipolar forceps and Heinrich 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.
7
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE & PERFORMANCE DATA
Table 1: Comparison of subject device, Heinrich Single Use Non-Stick Irrigating Bipolar Forceps with Cable with predicate device, Synergetics Disposable Single Use Dual Irrigating Standard Bipolar Forceps- K110924
| Irrigating Standard Bipolar Forceps- K110924 | |||
|---|---|---|---|
| Feature | Subject Device | Predicate Device | Justification For |
| Differences | |||
| Heinrich Single Use | |||
| Non-Stick Irrigating | |||
| Bipolar Forceps with | |||
| Cable | |||
| (one model with | |||
| different sizes) | Synergetics | ||
| Disposable Single | |||
| Use Dual Irrigating | |||
| Standard Bipolar | |||
| Forceps K110924 | |||
| Manufacturer | HG Innovations Ltd. | Synergetics, Inc | ------- |
| Regulation | 878.4400 | 878.4400 | Same |
| Classification 21 | Class II | Class II | Same |
| Product Code | GEI | GEI | Same |
| Device Description | The Heinrich single- | ||
| use, non-stick | |||
| irrigating bipolar | |||
| forceps (various | |||
| sizes), 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 | The SynergeticsTm | ||
| Disposable | |||
| Spetzlefrm Malis® | |||
| Standard Bipolar | |||
| Forceps are sterile | |||
| single use devices | |||
| for use in | |||
| electrosurgery. The | |||
| forceps are a | |||
| bayonet style and | |||
| include a cord at the | |||
| proximal end which | |||
| allows for | |||
| connection to a | |||
| Malis bipolar | |||
| electrosurgical | |||
| generator. | Similar | ||
| forceps must only be | |||
| used with bipolar | |||
| coagulation current. | |||
| 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. | |||
| Heinrich 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. | |||
| Heinrich 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: | Sterile, single use, | ||
| for use in | |||
| electrosurgery for | |||
| coagulation and | |||
| irrigation of tissue. | Same | ||
| -ENT | |||
| -Gynecology | |||
| -Urology | |||
| -General Surgery | |||
| -Neurosurgery | |||
| -Laryngeal Surgery | |||
| -Orthopedic | |||
| Surgery | |||
| -Thoracic Surgery | |||
| Heinrich single-use | |||
| non-stick irrigating | |||
| bipolar forceps are | |||
| connected through | |||
| a suitable bipolar | |||
| cable with the | |||
| bipolar output of an | |||
| electrosurgical | |||
| generator. Heinrich | |||
| single-use non-stick | |||
| bipolar forceps and | |||
| Heinrich 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. | |||
| For Use with | Electrosurgical | ||
| generators, irrigation | |||
| modules and | |||
| irrigation tubing | Electrosurgical | ||
| generators, irrigation | |||
| modules and | |||
| irrigation tubing | Same | ||
| Irrigation Tube | |||
| Connection | Connects to irrigation | ||
| port that's connected | |||
| to main housing | Connects to | ||
| irrigation port that's | |||
| connected to main | |||
| housing | Similar | ||
| Delivery Line to distal | |||
| end of forceps | Yes | Yes | Same |
| Irrigation Pipe | PVC, silicone | N/A | |
| Rx/ OTC | Rx | Rx | Same |
| Design | Bayonet | Bayonet | Same |
| Energy Source | Generator | Generator | Same |
| Single Use | Yes | Yes | Same. Disposable |
| use of subject | |||
| device reduces risk. | |||
| Electrode Type | Bipolar | Bipolar | Same |
| Tip Sizes | 0.5mm, 1mm, 1.5mm | 0.5mm, 1mm, | |
| 1.5mm | Range of tip sizes is | ||
| identical. Larger tip | |||
| will decrease | |||
| current density and | |||
| last longer than | |||
| smaller tips. | |||
| Lengths | 180mm, 200mm, | ||
| 230mm | 177.8mm-228.6mm | ||
| ** Tip and length | |||
| sizes obtained from | |||
| marketing brochure | Range of lengths is | ||
| similar and largely | |||
| overlaps with | |||
| predicate device. | |||
| Component Materials | |||
| Forceps' Tip(s) | Silver Plated | Silver Plated | Forceps tip |
| materials are | |||
| identical | |||
| Arm Material | Aluminum | Aluminum | 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 | PVDF | Both are made of | |
| plastic and are non | |||
| patient contacting | |||
| Colorant | Pigment Blue 15:3 | ||
| UN8632 | N/A | N/A | |
| Forging Blank | Aluminum | 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) | Ethylene Oxide (EO) | Same. |
| Shelf-Life Testing | Real-time aging study | ||
| shows product shelf | |||
| life up to 3 years | N/A | N/A | |
| Performance Testing | |||
| Biocompatibility | |||
| (ISO10993-1) | 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- |
-
| Pass | Pass | Subject device and
predicate device
both passed
electromagnetic
compatibility testing
and electrical safety
testing which
includes mechanical
strength and
functionality testing. |
| Feature | Subject Device | Predicate Device | Justification For Differences |
| Manufacturer | Heinrich Single Use
Non-Stick Bipolar
Forceps with Cable –
(one model with
different sizes) | Sutter Swyng®
nonstick
bipolar forceps,
single-use –
K193587 | |
| Manufacturer | HG Innovations Ltd. | Sutter
Medizintechnik
GmbH | ---------- |
| Regulation | 878.4400 | 878.4400 | Same |
| Classification 21 | Class II | Class II | Same |
| Product Code | GEI | GEI | Same |
| Device Description | The Heinrich single-use, non-stick bipolar
forceps (various sizes and tip
configurations), with
preattached cables are designed to
grasp, manipulate,
coagulate 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 | Sutter Swyng® non-
stick bipolar forceps,
single-use are
electrosurgical
instruments. The
bipolar forceps are
provided with
bayonet-style handle
design with straight
or angled tips and
different total
lengths. They are to
be connected
through an
appropriate bipolar
cable with the
bipolar output of an
electrosurgical
generator. The
electrodes are
provided sterile and
are single-use
instruments. | Similar |
| | used with bipolar
coagulation current. | | |
| Indications for use | Heinrich Single-use
non-stick bipolar
forceps are intended
for use by a physician
familiar with
electrosurgery for
bipolar coagulation of
tissue for general
open surgery where
coagulation of soft
tissue is needed.
Heinrich 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.
Heinrich 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:
-ENT
-Gynecology
-Urology
-General Surgery
-Neurosurgery
-Laryngeal Surgery
-Orthopedic Surgery | Sutter Swyng® non-
stick bipolar forceps,
single-use are
intended for use in
electrosurgery for
coagulation of
tissue. | Same |
| | | | |
| | Heinrich Single-use
non-stick bipolar
forceps are
connected through a
suitable bipolar cable
with the bipolar output
of an electrosurgical
generator. Heinrich
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. | | |
| Rx/ OTC | Rx | Rx | Same |
| Design | Bayonet | Bayonet | Same |
| Energy Source | Generator | Generator | Same |
| Single Use | Yes | Yes | Same. Disposable
use of subject
device reduces risk. |
| Maximum Peak Voltage | 600 Vp | 500 Vp | Although subject
device has a slightly
higher maximum
voltage, it has duly
passed electrical
safety testing and
therefore, the higher
max voltage does
not raise any
questions of device
safety. |
| Electrode Type | Bipolar | Bipolar | Same |
| Tip Sizes | 0.5mm, 1mm, 1.5mm | 0.5mm, 1mm,
1.5mm | Range of tip sizes is
identical. Larger tip
will decrease
current density and
last longer than
smaller tips. |
| Lengths | 180mm, 200mm,
230mm | Different lengths,
specifics N/A | N/A |
| Component Materials | | | |
| Forceps' Tip(s) | Silver and Rhodium
Plated | Silver and Rhodium
Plated | Forceps tip
materials are
identical |
| Arm Material | Aluminum | Aluminum | 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 | Similar |
| Colorant | Pigment Blue 15:3
UN8632 | N/A | N/A |
| Forging Blank | Aluminum | 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 | Both are recognized
sterility methods. |
| Shelf-Life Testing | Real-time aging study
shows product shelf
life up to 3 years | aging study
established product
shelf life up to 3
years | Identical |
| Performance Testing | | | |
| | | | |
| Biocompatibility
(ISO10993-1) | Pass | Pass | Subject devices is
demonstrably non-
cytotoxic, non-
irritating,
systemically non
toxic, non-
sensitizing and
passes pyrogenicity
testing. Predicate
device specifics not
available, but has
passed
biocompatibility
testing. |
| Electrical Safety &
EMC (AAMI/ANSI IEC
60601-1, IEC 60601-2-
2) | Pass | Pass | Subject device and
predicate device
both passed
electromagnetic
compatibility testing
and electrical safety
testing which
includes mechanical
strength and
functionality testing. |
8
9
10
11
12
Table 2: Comparison of subject device, Single Use Non-Stick Bipolar Forceps with with predicate device, Sutter Swyng® Nonstick Bipolar Forceps, Single-use - K193587
13
14
15
16
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.
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