(12 days)
No
The device description and performance studies focus on the mechanical and electrical properties of the bipolar forceps, with no mention of AI or ML.
Yes
The device is intended to remove tissue and control bleeding using high-frequency electrical current, which are therapeutic actions.
No
Explanation: The device is described as an electrosurgical device intended to remove tissue and control bleeding using high-frequency electrical current. Its function is to grasp, manipulate, and coagulate tissue, which are all therapeutic actions, not diagnostic ones. There is no mention of the device collecting, analyzing, or interpreting biological data for diagnostic purposes.
No
The device description clearly states that the device is a physical electrosurgical handpiece (forceps) made of stainless steel or titanium, not software.
Based on the provided text, the Titan Manufacturing Bipolar Forceps are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "remove tissue and control bleeding by use of high frequency electrical current" during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The device is described as an "electrosurgical device (handpiece)/active accessory" used with an electrosurgical generator. This further confirms its use in surgical procedures.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) outside the body.
- Providing information about a patient's health status, diagnosis, or monitoring.
- Using reagents or calibrators.
The device is clearly intended for surgical intervention on a living patient, which falls under the category of a surgical instrument or electrosurgical accessory, not an IVD.
N/A
Intended Use / Indications for Use
Titan Manufacturing Bipolar Forceps are intended to remove tissue and control bleeding by use of high frequency electrical current.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Titan Manufacturing Bipolar Forcep is a generic electrosurgical device (handpiece)/active accessory that is to be connected through a bipolar cable with the bipolar output of a standard, general electrosurgical generator unit (ESU) and footswitch. The bipolar cable, ESU and footswitch are not part of the subject device, therefore not included in this submission. The subject device is not an electrosurgical vessel sealer system.
Titan Manufacturing Bipolar Forceps are indicated for use in general surgical procedures; designed to grasp, manipulate, and coagulate selected tissue.
Titan Manufacturing Bipolar Forceps are to be connected through a suitable bipolar cable [not supplied by Titan Manufacturing, Inc.] with the bipolar output of a standard, general electrosurgical generator [not supplied by Titan Manufacturing, Inc.]. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch [not supplied by Titan Manufacturing, Inc.].
Titan Manufacturing, Inc., offers an extensive line of precision crafted reusable stainless steel and titanium bipolar forceps in a multitude of handle styles, lengths, and tip sizes. Titan Manufacturing Bipolar Forceps are available in styles such as but not limited to straight and bayonet styles, patterned designs such as but not limited to Semkin, Jewelers, Adson, Scoville-Greenwood, Ti Square Grip, Yargasil, Tenzel, McPherson, and Cozean, etc. Titan Manufacturing offers bipolar forceps in lengths from approximately 3 ½ inches to 10 ¾ inches ; titanium or stainless steel; insulated or non-insulated; irrigating or non-irrigating; straight, curved, angled or coaptation; and varying tip sizes from 0.2mm to 2.0mm. The product line is similar to those offered by other wellestablished bipolar forcep manufacturers [e.g., Codman, Kirwin, Faulhaber Pinzetten, Synergetics (a.k.a. Stryker), etc.].
Titan Manufacturing Bipolar Forceps are reusable medical devices, provided non-sterile and must be cleaned and sterilized prior to use. They are used with the bipolar output for standard, general electrosurgical generators (ESU). The Titan Manufacturing Bipolar Forceps are compatible with general electrosurgical generators with 4mm outlets; U.S. 2-pin plugs. Bipolar cables, ESU and footswitch are not part of the subject device.
Titan Manufacturing Bipolar Forceps are available in four (4) general model types in stainless steel or titanium: Non-insulated; Insulated; Non-insulated/Irrigating; and Insulated/Irrigating.
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
Not Found
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)
Nonclinical testing has been conducted to verify that the Titan Manufacturing Bipolar Forceps met all design specifications and are substantially equivalent to the predicate devices. Testing included the following:
- Biocompatibility Testing performed in accordance with the following:
- ISO 10993-5:2009 "Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Test"
- ISO 10993-10:2010 "Biological Evaluation of Medical Devices Part 10: Skin Sensitization Test"
- ISO 10993-10:2010 "Biological Evaluation of Medical Devices Part 10: Skin Intracutaneous Reactivity Test"
- USP 151 Material Mediated Pyrogenicity Rabbit Pyrogen Test
- ISO 10993-11: "Biological Evaluation of Medical Devices Part 11: Tests for Acute Systemic Toxicity"
- ISO 10993-4:2017 "Biological Evaluation of Medical Devices Part 4, Selection of Tests for Interactions with Blood"
- Medical Electrical Equipment Safety Testing performed in accordance with the following: IEC 60601-2-2 Ed. 6 (2017)
- Cleaning and Sterilization Recommendations IFU Validation
In addition, Titan Manufacturing Bipolar Forceps have been compared to the predicate device through various performance studies designed to test visual/operational use, performance and electrical safety and effectiveness.
The testing results demonstrated the Titan Manufacturing Bipolar Forceps performed equivalent to the predicate devices.
- Current vs. New Kynar Equivalency Tests | Validation - Change in Kynar Insulation Coating Material Supplier]:
- Sprayability;
- Durability (Stress) Drop;
- Finish/Appearance;
- Heat;
- Hipot: and
- Continuity.
The testing results demonstrated the Titan Manufacturing Bipolar Forceps performed equivalent to the predicate devices.
Electrical performance of the device was completed following FDA Guidance "Premarket Notification [510(k) Submissions for Electrosurgical Devices for General Surgery", issued August 15, 2016. This required (thermal spread) testing on three (3) different tissue types at minimum, default, and maximum generator power to simulate thermal spread across different tissue types. The spread was then measured and recorded, compared to predicate devices. Results demonstrated an equivalent thermal spread under the same conditions across the different tissue types and power settings.
There were no clinical trials performed on these devices.
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.
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
October 25, 2021
Titan Manufacturing, Inc. % Prithul Bom Regulatory Technology Services, LLC 1000 Westgate Drive Suite #510k Saint Paul, Minnesota 55114
Re: K213386
Trade/Device Name: Titan Manufacturing Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 12, 2021 Received: October 13, 2021
Dear Prithul Bom:
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 (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 cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdth/cfdocs/cfpmn/pmn.cfm 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.
1
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 (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Leam (https://www.fda.gov/training-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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website assistance/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.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213386
Device Name Titan Manufacturing Bipolar Forceps
Indications for Use (Describe)
Titan Manufacturing Bipolar Forceps are intended to remove tissue and control bleeding by use of high frequency electrical current.
| 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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3
Image /page/3/Picture/0 description: The image shows the logo for Titan Manufacturing Inc. The logo features a stylized Spartan helmet on the left and the company name in bold, black letters on the right. Below the logo is the text "K213386" enclosed in a rectangular box.
Ph: (610) 935-8203 Fx: (610)933-9771 www.titanmfg.com
510(k) Summary
Device Name: Titan Manufacturing Bipolar Forceps
| Submission Sponsor: | Titan Manufacturing, Inc. | |
|---|---|---|
| Contact Person: | Donald Seavey, President | |
| Address/Phone#/Email: | Owner Operator: | |
| 1 Rapps Run | ||
| Malvern, PA 19355 | ||
| 610-935-8203 | ||
| don@titanmfg.com | Manufacturing Site: | |
| 818 Jefferson St | ||
| Fall River, MA 02721 | ||
| 610-935-8203 | ||
| don@titanmfg.com | ||
| Owner Operator/Manufacturing | ||
| Site Establishment Registration #s: | 9025545 | 3001452522 |
| Submission Correspondent: | WolfKat Regulatory Consulting, LLC. |
|---|---|
| Contact Person: | Katrina Fiedler, Founder & Principal Consultant |
| Address/Phone#/Email: | 44 Oxford Drive |
| East Windsor, NJ 08520 | |
| 609-902-6162 | |
| katrina@wolfkatreg.com |
| Date of Preparation: | October 22, 2021 [REVISED] |
|---|---|
| ---------------------- | ---------------------------- |
| Type of Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| --------------------- | ------------------------------------------- |
| Device Identification | |
|---|---|
| Trade/Proprietary Name: | Titan Manufacturing Bipolar Forceps |
| Common Name: | Bipolar Forceps |
| Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Regulation Number: | §878.4400 |
| Product Code: | GEI |
| Review Panel: | General & Plastic Surgery |
| Predicate Devices
| 510(k) # | Product Name | Manufacturer |
|---|---|---|
| K974593 | Semkin Insulated Bipolar Forcep | Titan Manufacturing, Inc. |
| K974594 | Semkin Bipolar Forcep | Titan Manufacturing, Inc. |
| K974595 | Cushing Bayonet Insulated Bipolar Forcep | Titan Manufacturing, Inc. |
These predicates have not been subject to a design-related recall.
4
Image /page/4/Picture/0 description: The image contains the logo for Titan Manufacturing Inc. The logo features a stylized helmet on the left and the company name on the right. Below the logo is the alphanumeric code K213386.
Ph: (610) 935-8203 Fx: (610)933-9771 www.titanmfg.com
| Reference Device
| 510(k) # | Product Name | Manufacturer |
|---|---|---|
| K121426 | Synergetics Disposable Spetzler Malis Standard | |
| Bipolar Forceps | Synergetics | |
| K182773 | Faulhaber Pinzetten OHG Single-Use Non-Stick Bipolar | |
| Forceps sterile/non-sterile; | ||
| Faulhaber Pinzetten OHG Single-Use Bipolar Irrigating | ||
| forceps sterile/non-sterile | Faulhaber Pinzetten OHG |
Indications For Use
Titan Manufacturing Bipolar Forceps are intended to remove tissue and control bleeding by use of high frequency electrical current.
Device Description
Titan Manufacturing Bipolar Forcep is a generic electrosurgical device (handpiece)/active accessory that is to be connected through a bipolar cable with the bipolar output of a standard, general electrosurgical generator unit (ESU) and footswitch. The bipolar cable, ESU and footswitch are not part of the subject device, therefore not included in this submission. The subject device is not an electrosurgical vessel sealer system.
Titan Manufacturing Bipolar Forceps are indicated for use in general surgical procedures; designed to grasp, manipulate, and coagulate selected tissue.
Titan Manufacturing Bipolar Forceps are to be connected through a suitable bipolar cable [not supplied by Titan Manufacturing, Inc.] with the bipolar output of a standard, general electrosurgical generator [not supplied by Titan Manufacturing, Inc.]. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch [not supplied by Titan Manufacturing, Inc.].
Titan Manufacturing, Inc., offers an extensive line of precision crafted reusable stainless steel and titanium bipolar forceps in a multitude of handle styles, lengths, and tip sizes. Titan Manufacturing Bipolar Forceps are available in styles such as but not limited to straight and bayonet styles, patterned designs such as but not limited to Semkin, Jewelers, Adson, Scoville-Greenwood, Ti Square Grip, Yargasil, Tenzel, McPherson, and Cozean, etc. Titan Manufacturing offers bipolar forceps in lengths from approximately 3 ½ inches to 10 ¾ inches ; titanium or stainless steel; insulated or non-insulated; irrigating or non-irrigating; straight, curved, angled or coaptation; and varying tip sizes from 0.2mm to 2.0mm. The product line is similar to those offered by other wellestablished bipolar forcep manufacturers [e.g., Codman, Kirwin, Faulhaber Pinzetten, Synergetics (a.k.a. Stryker), etc.].
Titan Manufacturing Bipolar Forceps are reusable medical devices, provided non-sterile and must be cleaned and sterilized prior to use. They are used with the bipolar output for standard, general electrosurgical generators (ESU). The Titan Manufacturing Bipolar Forceps are compatible with
5
Image /page/5/Picture/0 description: The image shows the logo for Titan Manufacturing Inc. The logo includes a stylized gray helmet on the left and the company name in black on the right. Below the company name, there is a box with the text "K213386" inside.
Ph: (610) 935-8203 Fx: (610)933-9771 www.titanmfg.com
general electrosurgical generators with 4mm outlets; U.S. 2-pin plugs. Bipolar cables, ESU and footswitch are not part of the subject device.
Titan Manufacturing Bipolar Forceps are available in four (4) general model types in stainless steel or titanium: Non-insulated; Insulated; Non-insulated/Irrigating; and Insulated/Irrigating.
| Comparison [Subject Device vs. Predicate Devices] | | | | | Same or
Different |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| | Subject Device | Predicate Device | Predicate Device | Predicate Device | |
| 510(k) Number | K213386 | K974593 | K974594 | K974595 | -- |
| Product Name | Titan Manufacturing
Bipolar Forceps | Semkin Insulated
Bipolar Forcep | Semkin Bipolar Forcep | Cushing Bayonet,
Insulated Bipolar Forcep | -- |
| Manufacturer | Titan
Manufacturing, Inc. | Titan
Manufacturing, Inc. | Titan
Manufacturing, Inc. | Titan
Manufacturing, Inc. | SAME |
| Classification | Class II | Class II | Class II | Class II | SAME |
| Subsequent Product
Code | GEI | GEI | GEI | GEI | SAME |
| Regulation | 878.4400 | 878.4400 | 878.4400 | 878.4400 | SAME |
| Rx or OTC | Rx | Rx | Rx | Rx | SAME |
| Intended Use | Titan Manufacturing
Bipolar Forceps are
intended to remove
tissue and control
bleeding by use of
high frequency
electrical current. | Semkin Insulated
Bipolar Forceps are
intended to remove
tissue and control
bleeding by use of high
frequency electrical
current. | Semkin Bipolar
Forceps are intended to
remove tissue and
control bleeding by use
of high frequency
electrical current. | Cushing Bayonet,
Insulated Bipolar Forceps
are intended to remove
tissue and control
bleeding by use of high
frequency electrical
current. | SAME |
| Principles
of
Operation | Bipolar forceps are
designed to grasp,
manipulate, and
coagulate selected
tissue. They are to be
connected through a
bipolar cable with the
bipolar output of an
electrosurgical
generator.
Coagulation is achieved
using electrosurgical
energy generated by the
electrosurgical generator
unit (ESU) and activated
by a footswitch. | Bipolar forceps are
designed to grasp,
manipulate, and
coagulate selected
tissue. They are to be
connected through a
bipolar cable with the
bipolar output of an
electrosurgical
generator. Coagulation
is achieved using
electrosurgical energy
generated by the
electrosurgical
generator unit (ESU)
and activated by a
footswitch. | Bipolar forceps are
designed to grasp,
manipulate, and
coagulate selected
tissue. They are to be
connected through a
bipolar cable with the
bipolar output of an
electrosurgical
generator. Coagulation
is achieved using
electrosurgical energy
generated by the
electrosurgical
generator unit (ESU)
and activated by a
footswitch. | Bipolar forceps are designed
to grasp, manipulate, and
coagulate selected tissue.
They are to be connected
through a bipolar cable with
the bipolar output of an
electrosurgical generator.
Coagulation is achieved
using electrosurgical energy
generated by the
electrosurgical generator
unit (ESU) and activated by
a footswitch. | SAME |
| | Bipolar cables, ESU and
footswitch are not part
of the subject
device. | Bipolar cables, ESU
and footswitch are not
part of the subject
device. | Bipolar cables, ESU
and footswitch are not
part of the subject
device. | Bipolar cables, ESU and
footswitch are not part of the
subject device. | |
| Electrode Type | Bipolar | Bipolar | Bipolar | Bipolar | SAME |
| Physical Dimensions
Available | 3 ½ inches to
10 ¾ inches in length | 3 ½ inches to
10 ¾ inches in length | 3 ½ inches to
10 ¾ inches in length | 3 ½ inches to
10 ¾ inches in length | SAME |
| Tip Sizes Available | 0.2mm to 2.0mm | 0.2mm to 2.0mm | 0.2mm to 2.0mm | 0.2mm to 2.0mm | SAME |
Substantial Equivalence Discussion Comparison [Subiect Device vs. Predicate Devices]
6
Image /page/6/Picture/0 description: The image contains a logo for Titan Manufacturing Inc. The logo features a stylized Spartan helmet on the left and the company name on the right. Below the logo is the alphanumeric code K213386.
Ph: (610) 935-8203 Fx: (610)933-9771 www.titanmfg.com
Substantial Equivalence Discussion Comparison [Subject Device vs. Predicate Devices]
(cont'd)
| | Subject Device | Predicate Device | Predicate Device | Predicate Device | Same or
Different |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| | Materials | Stainless Steel or
Titanium | Stainless Steel or
Titanium | Stainless Steel or
Titanium | Stainless Steel or
Titanium |
| | | Epoxy | Epoxy | Epoxy | Epoxy |
| | Kynar
Insulation Coating
[Polyvinylidene
Fluoride (PVDF)] | Kynar
Insulation
Coating
[Polyvinylidene
Fluoride (PVDF)] | Kynar
Insulation
Coating
[Polyvinylidene
Fluoride (PVDF)] | Kynar
Insulation Coating
[Polyvinylidene Fluoride
(PVDF)] | |
| Visual Appearance
Insulated Bipolar
Forceps | Lighter, semi-gloss,
blue-colored
insulating coating
material | Dark, matte, blue-
colored insulating
coating material | Dark, matte, blue-
colored insulating
coating material | Dark, matte, blue-colored
insulating coating
material | SIMILAR -
blue colorant,
Kynar |
| Sterilization
Recommendations | Pre-Vacuum Steam | Pre-Vacuum Steam | Pre-Vacuum Steam | Pre-Vacuum Steam | SAME |
| Re-usable | YES | YES | YES | YES | SAME |
| Packaging | Bipolar forcep in a
propionate clear hard
plastic tube with foam
insets at both ends
packaged in an
instrument sturdy box
with packaging
material to protect the
instrument (bipolar
forcep) | Bipolar forcep in a
propionate clear hard
plastic tube with foam
insets at both ends
packaged in an
instrument sturdy box
with packaging
material to protect the
instrument (bipolar
forcep) | Bipolar forcep in a
propionate clear hard
plastic tube with foam
insets at both ends
packaged in an
instrument sturdy box
with packaging
material to protect the
instrument (bipolar
forcep) | Bipolar forcep in a
propionate clear hard
plastic tube with foam
insets at both ends
packaged in an
instrument sturdy box
with packaging material
to protect the instrument
(bipolar forcep) | SAME |
| Biocompatible | YES | YES | YES | YES | SAME |
|
Drop Test
Cable Connector Type | YES
Compatible with U.S.
2-pin round plugs | YES
Compatible with U.S.
2-pin round plugs | YES
Compatible with U.S.
2-pin round plugs | YES
Compatible with U.S. 2-
pin round plugs | SAME
SAME |
| Electrical Safety
Features | HiPot & Continuity
Test Dielectric
strength insulation;
insulated safety plug;
Compatible with
general
electrosurgical
generators with 4mm
outlets | HiPot & Continuity
Test Dielectric strength
insulation; insulated
safety plug:
Compatible with
general electrosurgical
generators with 4mm
outlets | HiPot & Continuity
Test Dielectric strength
insulation; insulated
safety plug;
Compatible with
general electrosurgical
generators with 4mm
outlets | HiPot & Continuity Test
Dielectric strength
insulation; insulated
safety plug;
Compatible with general
electrosurgical generators
with 4mm outlets | SAME |
7
Image /page/7/Picture/0 description: The image shows the logo for Titan Manufacturing Inc. The logo features a stylized helmet on the left, followed by the word "Titan" in a bold, sans-serif font with a green dot above the "i". Below "Titan" is the text "Manufacturing Inc." in a smaller font. There is also a box with the text "K212286".
Ph: (610) 935-8203 Fx: (610)933-9771 www.titanmfg.com
Comparison [Subject Device vs. Reference Devices]
| Subject Device | Reference Device #1 | Reference Device #2 | Same or Different | |
|---|---|---|---|---|
| 510(k) Number | K213386 | K121426 | K182773 | ------------------------- |
| Product Name | Titan Manufacturing | |||
| Bipolar Forceps | Synergetics Disposable Spetzler | |||
| Malis Standard Bipolar Forceps | Faulhaber Pinzetten OHG Single- | |||
| Use Non-Stick Bipolar Forceps | ||||
| sterile/non-sterile; | ||||
| Faulhaber Pinzetten OHG Single- | ||||
| Use Bipolar Irrigating forceps | ||||
| sterile/non-sterile | ------------------------- | |||
| Manufacturer | Titan | |||
| Manufacturing, Inc. | Synergetics | Faulhaber Pinzetten OHG | ------------------------- | |
| Classification | Class II | Class II | Class II | SAME |
| Product Code | GEI | GEI | GEI | SAME |
| Regulation | 878.4400 | 878.4400 | 878.4400 | SAME |
| Rx or OTC | Rx | Rx | Rx | SAME |
| Intended Use | Titan Manufacturing | |||
| Bipolar Forceps are | ||||
| intended to remove | ||||
| tissue and control | ||||
| bleeding by use of | ||||
| high frequency | ||||
| electrical current. | The Synergetics Disposable | |||
| Spetzler-Malis Standard Bipolar | ||||
| Forceps are single use device | ||||
| sold sterile and are intended for | ||||
| use in electrosurgery for | ||||
| coagulation of tissue. | Faulhaber Single Use Non-Stick | |||
| Bipolar Forceps sterile/non-sterile | ||||
| and Single-Use Non-Stick Bipolar | ||||
| 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 | ||||
| validated cleaning, disinfection, and | ||||
| sterilization process. | ||||
| The 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 are: | ||||
| -General surgery | ||||
| -Laryngeal coagulation | ||||
| -Orthopedic coagulation | ||||
| -Thoracic coagulation | ||||
| -Neurosurgical coagulation | ||||
| Gynecological coagulation (except | ||||
| for use in sterilization) | ||||
| -Urological coagulation | ||||
| -Ear, Noe, Throat coagulation. | SIMILAR – Intended | |||
| use for subject device | ||||
| is general; | ||||
| Subject device is | ||||
| reusable and provided | ||||
| non-sterile. |
8
Image /page/8/Picture/0 description: The image shows the logo for Titan Manufacturing Inc. The logo features a stylized helmet on the left and the company name on the right. Below the logo is the text "K213386" in a box.
Ph: (610) 935-8203 Fx: (610)933-9771 www.titanmfg.com
Comparison [Subject Device vs. Reference Devices]
(cont'd)
| Subject Device | Reference Device #1 | Reference Device #2 | Same or Different | |
|---|---|---|---|---|
| Principles of | ||||
| Operation | Bipolar forceps are | |||
| designed to grasp. | ||||
| manipulate, and | ||||
| coagulate selected | ||||
| tissue. They are to be | ||||
| connected through a | ||||
| bipolar cable with | ||||
| the bipolar output of | ||||
| an electrosurgical | ||||
| generator. | ||||
| Coagulation is | ||||
| achieved using | ||||
| electrosurgical | ||||
| energy generated by | ||||
| the electrosurgical | ||||
| generator unit (ESU) | ||||
| and activated by a | ||||
| footswitch. | ||||
| Bipolar cables, ESU | ||||
| and footswitch are | ||||
| not part of the | ||||
| subject device. | Bipolar forceps are designed to | |||
| grasp, manipulate, and coagulate | ||||
| selected tissue. They are to be | ||||
| connected through a bipolar | ||||
| cable with the bipolar output of | ||||
| an electrosurgical generator. | ||||
| Coagulation is achieved using | ||||
| electrosurgical energy generated | ||||
| by the electrosurgical generator | ||||
| unit (ESU) and activated by a | ||||
| footswitch. | ||||
| Bipolar cables, ESU and | ||||
| footswitch are required for | ||||
| operation, but not provided. | Bipolar forceps are designed to | |||
| grasp, manipulate, and coagulate | ||||
| selected tissue. They are to be | ||||
| connected through a bipolar cable | ||||
| with the bipolar output of an | ||||
| electrosurgical generator. | ||||
| Coagulation is achieved using | ||||
| electrosurgical energy generated by | ||||
| the electrosurgical generator unit | ||||
| (ESU) and activated by a footswitch. | ||||
| Bipolar cables, ESU and footswitch | ||||
| are required for operation, but not | ||||
| provided. | SAME | |||
| Electrode Type | Bipolar | Bipolar | Bipolar | SAME |
| Materials | Stainless Steel or | |||
| Titanium | ||||
| Epoxy | ||||
| Kynar® Insulation | ||||
| Coating | ||||
| [Polyvinylidene | ||||
| Fluoride PVDF)] | Stainless Steel or Titanium | |||
| Epoxy | ||||
| Insulation Coating | ||||
| [Polyvinylidene Fluoride | ||||
| (PVDF)] | Stainless Steel | |||
| Epoxy | ||||
| Insulation Coating | ||||
| [Rilsan (Nylon)] | SIMILAR - Brand of | |||
| PVDF not known for | ||||
| 1st cited reference | ||||
| device; Similar | ||||
| insulation coating | ||||
| material for 2nd cited | ||||
| reference device | ||||
| Biocompatible | YES | YES | YES | SAME |
| Cable Connector Type | Compatible with | |||
| U.S. 2-pin round | ||||
| plugs | Compatible with U.S. 2-pin | |||
| round plugs | Compatible with U.S. 2-pin round | |||
| plugs | SAME | |||
| Safety Features | Dielectric strength | |||
| insulated safety plug | Dielectric strength insulated | |||
| safety plug | Dielectric strength insulated safety | |||
| plug | SAME |
9
Image /page/9/Picture/0 description: The image contains a logo for Titan Manufacturing Inc. The logo features a stylized Spartan helmet on the left and the word "Titan" in bold, with a green dot above the "i". Below "Titan" is the text "Manufacturing Inc." In the bottom right corner of the image, there is a box containing the text "K213386".
Ph: (610) 935-8203 Fx: (610)933-9771 www.titanmfg.com
Non -Clinical Performance Testing
Nonclinical testing has been conducted to verify that the Titan Manufacturing Bipolar Forceps met all design specifications and are substantially equivalent to the predicate devices. Testing included the following:
- . Biocompatibility Testing performed in accordance with the following:
- ISO 10993-5:2009 "Biological Evaluation of Medical Devices Part 5: In Vitro o Cytotoxicity Test"
- ISO 10993-10:2010 "Biological Evaluation of Medical Devices Part 10: Skin O Sensitization Test"
- ISO 10993-10:2010 "Biological Evaluation of Medical Devices Part 10: Skin o Intracutaneous Reactivity Test"
- USP 151 Material Mediated Pyrogenicity Rabbit Pyrogen Test O
- ISO 10993-11: "Biological Evaluation of Medical Devices Part 11: Tests for Acute O Systemic Toxicity"
- ISO 10993-4:2017 "Biological Evaluation of Medical Devices Part 4, Selection of Tests O for Interactions with Blood"
- Medical Electrical Equipment Safety Testing performed in accordance with the following: ●
- o IEC 60601-2-2 Ed. 6 (2017)
- Cleaning and Sterilization Recommendations IFU Validation
In addition, Titan Manufacturing Bipolar Forceps have been compared to the predicate device through various performance studies designed to test visual/operational use, performance and electrical safety and effectiveness.
The testing results demonstrated the Titan Manufacturing Bipolar Forceps performed equivalent to the predicate devices.
- Current vs. New Kynar Equivalency Tests | Validation - Change in Kynar Insulation Coating Material Supplier]:
- 0 Sprayability;
- Durability (Stress) Drop; O
- Finish/Appearance; O
- Heat; O
- Hipot: and O
- Continuity. o
The testing results demonstrated the Titan Manufacturing Bipolar Forceps performed equivalent to the predicate devices.
Electrical performance of the device was completed following FDA Guidance "Premarket Notification [510(k) Submissions for Electrosurgical Devices for General Surgery", issued August 15, 2016. This required (thermal spread) testing on three (3) different tissue types at minimum, default, and maximum
10
Image /page/10/Picture/0 description: The image shows the logo for Titan Manufacturing Inc. The logo features a stylized Spartan helmet on the left. Below the logo is the alphanumeric code K213386.
Ph: (610) 935-8203 Fx: (610)933-9771 www.titanmfg.com
generator power to simulate thermal spread across different tissue types. The spread was then measured and recorded, compared to predicate devices. Results demonstrated an equivalent thermal spread under the same conditions across the different tissue types and power settings.
Clinical Performance Testing
There were no clinical trials performed on these devices.
Statement of Substantial Equivalence
The subject device has the same intended use and technological characteristics as the cited predicate devices. The minor changes or differences presented do not affect the safety or performance of the subject device or raise new questions of safety or effectiveness. The non-clinical test results have demonstrated the subject device is as safe as the predicate devices.
Therefore, it is concluded that no new questions of safety and effectiveness were raised. We conclude that the subject device is substantially equivalent to the cited predicate devices.