The Aquamantys single-use disposable Malleable Bipolar Sealer with Light is a sterile, bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedic, spine, thoracic, and open abdominal surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Device Description

The Aquamantys Malleable Bipolar Sealer is similar to the Aquamantys 6.0 Bipolar Sealer, cleared via K#052859, in that they are comprised of a pencil-grip handle which houses an electrode terminating at the distal tip. The Aquamantys Malleable Bipolar Sealer is constructed of the same medical device grade materials as the Aquamantys 6.0 except for the LED light circuit and over molded shaft. All biocompatibility data is on file at TissueLink Medical, Inc. A summary is included in Section 5 of this submission. The manufacture of both devices is similar, consisting of an electrode tip/shaft assembly extending out of an ergonomically designed clamshell body. Both devices have two parallel (along the axis of symmetry) electrodes stemming from the handle that are approximately 4-6 millimeters apart. Both devices are electrically insulated, leaving only the tip of each shaft electrically active. Like the Aquamantys 6.0 Bipolar Sealer, each tip of the Aquamantys Malleable is a smooth stainle cylinder with a hemispherical end. Each tip is set at a downward angle between 0° - 45° along the long axis of the device. The Aquamantys 6.0 device has a slot located on each tip oriented lateral to the handle towards the outside of the device, allowing saline to flow from the inner lumen of the hypotube to the electrode. The Aquamantys Malleable device incorporates a hole instead of a slot, similarly oriented lateral to the handle towards the outside of the device. The saline wets the outer surface of the stainless steel electrode tip in a manner identical to the Aquamantys 6.0 Bipolar Sealer. The device is not intended for use without saline. Ten (10) feet of saline tubing and electrical cord are routed distally from the handle. The distal end of the disposable electrical cord contains a standard three (3) prong paddle plug for connection to the Aquamantys Pump Generator System. The saline tubing is connected to an I.V. pump segment. The L.V. pump segment contains a 6" pump tubing portion for loading into the Aquamantys Pump portion of the Aquamantys Pump Generator System and a Drip Chamber/spike set for connection to the saline delivery source. The simultaneous application of saline irrigation and radio-frequency energy allows coagulation of bleeding tissue at much lower temperatures than conventional dry radiofrequency coagulation. This prevents the formation of surface eschar. Most conventional electrosurgical devices create a surface eschar that is hard and scab-like. The Aquamantys Malleable Bipolar Sealer has an optional illumination provided by a LED light positioned between the electrodes at the distal end of the device. It can be switched on or off with a button located on the handpiece and is used to illuminate the surgical site if needed. The Aquamantys Malleable Bipolar Sealer also incorporates a malleable shaft that can be bent by the user into various positions, while maintaining the functionality as identified in the product specifications.

AI/ML Overview

The provided text describes a Special 510(k) submission for the Aquamantys Malleable Bipolar Sealer with Light. This type of submission is used when a modification is made to an existing device that has already received 510(k) clearance, and the modification does not raise new questions of safety or effectiveness. As such, the study conducted is focused on demonstrating substantial equivalence to the predicate device, rather than establishing de novo performance metrics or diagnostic accuracies typically seen in AI/reader studies.

Therefore, many of the typical acceptance criteria and study details related to diagnostic accuracy, such as AUC, sensitivity, specificity, sample size for test sets with ground truth established by experts, MRMC studies, or standalone algorithm performance, are not applicable to this type of device and submission.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured)	Reported Device Performance (How the new device performed)
Technological Characteristics Equivalence	Shares the same fundamental technology as the predicate device (Aquamantys 6.0 Bipolar Sealer). Technology is based on simultaneous saline irrigation and RF power delivery, operating with the Aquamantys Pump Generator. No modifications to the Pump Generator software required.
Materials Equivalence	Constructed of the same medical device grade materials as the predicate, except for the LED light circuit and over molded shaft. All biocompatibility data is on file.
Design Equivalence (Electrode & Saline Delivery)	Similar design to predicate device. The Malleable device incorporates a hole instead of a slot for saline delivery, but is "similarly oriented lateral to the handle towards the outside of the device" and "wets the outer surface of the stainless steel electrode tip in a manner identical to the Aquamantys 6.0 Bipolar Sealer."
Functionality (Malleable Shaft)	The malleable shaft can be bent by the user into various positions while maintaining functionality as identified in product specifications.
Functionality (Optional Illumination)	Optional illumination provided by an LED light, switchable on/off via a button on the handpiece, used to illuminate the surgical site.
Biocompatibility	All biocompatibility data is on file (for the materials used, which are mostly the same as the predicate).
Overall Performance Equivalence to Predicate	"The performance of this device is substantially equivalent to the predicate device and performs as intended."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Description: The "test set" in this context refers to the modifications and features of the new device that were evaluated against the predicate device's established performance and specifications. This is not a clinical test set from patient data.
Sample Size: Not applicable in the traditional sense of a clinical trial. The evaluation involved comparing the design, materials, and functional aspects of the new device to the predicate device and internal specifications.
Data Provenance: Not applicable in terms of patient data origin. The data provenance would be from internal engineering and material testing within TissueLink Medical, Inc.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. Ground truth, in the sense of expert consensus on diagnostic findings, is not relevant for this engineering and equivalence testing. The "ground truth" here is the established function and safety of the predicate device and the design specifications of the new device.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring expert adjudication of findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not performed on these devices." This type of study focuses on device modifications and their impact on human interpretation or intervention, which isn't typically required for a Special 510(k) where substantial equivalence is demonstrated through engineering and performance testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This is not an AI/algorithm-based device. "Standalone performance" in this context would refer to the device's functional performance according to its specifications, which was implicitly done through nonclinical testing.

7. The Type of Ground Truth Used

Engineering Specifications and Predicate Device Performance: The "ground truth" against which the new device was evaluated consisted of the established performance characteristics and safety profile of the predicate device (Aquamantys 6.0 Bipolar Sealer, K#052859) and internal engineering and quality specifications of TissueLink Medical, Inc.
The goal was to demonstrate that the changes (malleable shaft, LED light, saline delivery hole instead of slot) did not alter the fundamental safety and effectiveness or introduce new risks, thus maintaining substantial equivalence to the predicate.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. See point 8.

Summary

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Special 510(k): TissueLink Medical, Inc. - Aquamantys Malleable Bipolar Sealer with Light

K073495

510(k) Summary of Safety and Effectiveness

This summary of 510(k)-safety and effectiveness information is being submitted in a requirements of SMDA 1990 and 21 CFR 807.92.

Application Information:

Date Prepared:	December 11, 2007
Submitter:	TissueLink Medical Inc.
Address:	One Washington Center Suite 400Dover, NH 03820
Contacts:	Som KovvuriVice President, Regulatory Affairs & Quality Assurance
Telephone Number:	(603) 742-1515 ext. 109
FAX Number:	(603) 742-1488

Device Information:

Trade Name:	Aquamantys Malleable Bipolar Sealer with Light
Common Name:	Electrosurgery Bipolar Sealer
Classification Name:	Electrosurgical cutting and coagulation device and accessories - 21CFR
	878.4400

Predicate Devices:

Claim of Substantial Equivalence of the Aquamantys Malleable Bipolar Sealer with Light is made to:

Name:	Aquamantys 6.0 Bipolar Sealer (Part of the TissueLink AquamantysPump Generator System)
510(k) Number	K#052859
Regulation Number	878-4400 Device, Electrosurgical, Cutting & Coagulation & Accessories
Product Code	GEI
Decision Date	October 25, 2005

Device Description

Both devices are electrically insulated, leaving only the tip of each shaft electrically active.

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K073495

Special 510(k): TissueLink Medical, Inc. – Aquamantys Malleable Bipolar Sealer with Light

Like the Aquamantys 6.0 Bipolar Sealer, each tip of the Aquamantys Malleable is a smooth stainle cylinder with a hemispherical end. Each tip is set at a downward angle between 0° - 45° along the long axis of the device. The Aquamantys 6.0 device has a slot located on each tip oriented lateral to the handle towards the outside of the device, allowing saline to flow from the inner lumen of the hypotube to the electrode. The Aquamantys Malleable device incorporates a hole instead of a slot, similarly oriented lateral to the handle towards the outside of the device. The saline wets the outer surface of the stainless steel electrode tip in a manner identical to the Aquamantys 6.0 Bipolar Sealer. The device is not intended for use without saline.

Ten (10) feet of saline tubing and electrical cord are routed distally from the handle. The distal end of the disposable electrical cord contains a standard three (3) prong paddle plug for connection to the Aquamantys Pump Generator System. The saline tubing is connected to an I.V. pump segment. The L.V. pump segment contains a 6" pump tubing portion for loading into the Aquamantys Pump portion of the Aquamantys Pump Generator System and a Drip Chamber/spike set for connection to the saline delivery source.

The simultaneous application of saline irrigation and radio-frequency energy allows coagulation of bleeding tissue at much lower temperatures than conventional dry radiofrequency coagulation. This prevents the formation of surface eschar. Most conventional electrosurgical devices create a surface eschar that is hard and scab-like.

The Aquamantys Malleable Bipolar Sealer has an optional illumination provided by a LED light positioned between the electrodes at the distal end of the device. It can be switched on or off with a button located on the handpiece and is used to illuminate the surgical site if needed.

The Aquamantys Malleable Bipolar Sealer also incorporates a malleable shaft that can be bent by the user into various positions, while maintaining the functionality as identified in the product specifications.

Image /page/1/Figure/7 description: This image shows a medical device with several labeled parts. The device has a malleable shaft with electrode tips and a light at the end. The handpiece has buttons to activate RF power, saline flow, and operate the light, and it is connected to a saline line, electrical cable, plug, drip chamber, and pump tubing.

Figure 1:Aquamantys Malleable Bipolar Sealer with Light - Side View

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K073495
Special 510(k): TissueLink Medical, Inc. Aquamantys Malleable Bipolar Sealer with Light

Page 3 8 (4)

Figure 2: A simple schematic of how the devices connect to other instruments.

Image /page/2/Figure/3 description: The image shows a diagram of the Aquamantys system. The system includes a patient, an Aquamantys single-use disposable Malleable Bipolar Sealer with Light, saline delivery tubing and RF cable, a bag of sterile saline (0.9% NaCl) solution, and an Aquamantys Pump Generator. The diagram shows how the different components of the system are connected.

Intended Use:

Contraindications:

The efficacy of the Aquamantys Malleable Bipolar Sealer with Light device for contraceptive tubal coagulation (permanent female sterilization) has not been evaluated and is not known.

Technological Characteristics:

The Aquamantys Malleable Bipolar Sealer with Light electrosurgical device shares the same fundamental technology as predicate device, the Aquamantys 6.0 Bipolar Sealer. The technology is based on simultaneous saline irrigation and RF power delivery. Both devices operate in conjunction with the Aquamantys Pump Generator. No modifications to the Aquamantys Pump Generator software are required for the use of the Aquamantys Malleable Bipolar Sealer with Light.

Nonclinical Performance:

The performance characteristics of the Aquamantys Malleable Bipolar Sealer with Light were tested and compared with performance specifications established by TissueLink Medical, Inc. for the device.

Clinical Performance:

Clinical testing was not performed on these devices.

TissueLink Medical, Inc.

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Special 510(k): TissueLink Medical, Inc. – Aquamantys Malleable Bipolar Sealer with Light

K 0 73495

Conclusions from Nonclinical Tests:

The performance of this device is substantially equivalent to the predicate device and performs as intended.

Page 4 of (4)

TissueLink Medical, Inc.

・

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.

Public Health Service

JAN - 9 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TissueLink Medical, Inc. % Som Kovvuri VP, Regulatory Affairs & Quality Assurance One Washington Center, Suite 400 Dover, New Hampshire 03820

Re: K073495

Trade/Device Name: TissueLink Aquamantys Malleable Bipolar Sealer with Light Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 11, 2007 Received: December 12, 2007

Dear Som Kovvuri:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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); good manufacturing practice requirements as set

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Page 2 - Som Kovvuri

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k): TissueLink Medical, Inc. – Aquamantys Malleable Bipolar Sealer with Light

Indications for use Statement

Page

510(k) Number (if known): K073495

Device Name:

TissueLink Aquamantys Malleable Bipolar Sealer with Light

Indications for Use:

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

Optional Format 1-

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number. 16073495

TissueLink Medical, Inc.

Regulation Number and Section

§ 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.