The Axya Suture Welding System is indicated for use in securing sutures in soft tissues and for securing ligatures of tubular structures wherever conventional sutures or surgical staples are appropriate. The System may be used in arthroscopic, laparoscopic and open surgical procedures.

Device Description

The Suture Welding System described in this Notice is a fully disposable singlepatient-use hand-piece with an internal (battery) power supply/controller. This device is designed for use in securing a specific suture (Axya Medical Tufflex™ Polyester suture) with a weld rather than with a traditional knot. This reduces the bulk of the suture fastening point and eliminates the possibility of knot slippage. The single-patient-use device eliminates the need for repair and maintenance of suture welding devices with reusable power supply/control units.

AI/ML Overview

The provided text describes the Axya™ Suture Welding System and Kit, a device designed to secure sutures with a weld rather than a traditional knot. The submission aims to establish substantial equivalence to predicate devices.

Here's an analysis of the provided text in the context of the requested information, while noting that some information is not explicitly present in the provided document:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it relies on demonstrating equivalence to predicate devices and established standards.

Acceptance Criteria (Implied)	Reported Device Performance
Suture Holding Strength (Efficacy): Equivalent to conventional knotting techniques and above USP requirements for suture material.	"Data were presented which demonstrate that sutures placed by means of the suture welding process exhibit 'knot strength' characteristics above the USP requirements for the USP suture material tested. These tests confirm that sutures placed with the suture welding technology are equivalent in holding strength (efficacy) to sutures placed with conventional knotting techniques."
"Sutures welded in a fluid environment meet USP knot strength requirements."
Safety (Biocompatibility): No unusual adverse histopathologic change compared to traditional methods.	"In this animal model there was no unusual adverse histopathologic change seen at the suture implant sites where the suture was welded. The investigators concluded that there was no significant difference in safety of efficacy between the traditional method of suture placement and the technique which replaces manual knot-tying with suture welding."
Protection from Thermal Injury: Device design protects tissues.	"The design of the device protects tissues from potential thermal injury."
No New Chemical Entities: Welding process introduces no new chemical entities.	"No 'flux' or 'welding rod' is employed and no new chemical entities are introduced or produced in the welding process."
Sterility: Components are sterile. Validate processes.	"The single-patient-use components of the System and Kit are provided sterile. The sterility processes, the manufacturing process, and the packaging process are validated by the manufacturer."

Study Details:

Sample size used for the test set and the data provenance:
- In vitro studies: The specific sample size for the in vitro studies (e.g., number of welds tested for knot strength) is not provided.
- In vivo studies: The specific number of animals (New Zealand rabbits) used for the in vivo testing is not provided, though it mentions "bowel tissue of the New Zealand rabbit."
- Data Provenance: The document does not specify the country of origin of the data. The studies appear to be conducted by or for Axya Medical, Inc.
- Retrospective or Prospective: Both in vitro and in vivo studies described appear to be prospective in nature, designed specifically to test the device's performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- The document mentions "investigators" for the animal study ("The investigators concluded that there was no significant difference..."). However, the number and specific qualifications of these experts are not provided. For in vitro studies, it's implied that standard laboratory practices and personnel were involved in performing tests against USP requirements.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe any formal adjudication method like 2+1 or 3+1 for establishing ground truth from multiple experts. The conclusion from the animal study appears to be a consensus of the "investigators."
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a surgical tool, not an AI or imaging diagnostic tool that would typically involve human "readers" or AI assistance in interpretation. The comparison is between a device-secured suture and a manually-knotted suture in terms of physical performance and biological response.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question is not applicable as the device is a physical surgical tool and not an algorithm. Performance is assessed directly through physical and biological testing of the device's output (welded sutures).
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- In vitro: Ground truth for suture strength was established by USP (United States Pharmacopeia) requirements for suture materials.
- In vivo: Ground truth for safety/efficacy in the animal model was established through histopathologic evaluation (pathology) for adverse changes and likely observed functionality/healing, with conclusions drawn by "investigators."
The sample size for the training set:
- This concept is not applicable to this type of medical device. The Axya Suture Welding System is a mechanical/thermal device, not an AI-based system that requires a "training set."
How the ground truth for the training set was established:
- This question is not applicable for the reasons stated above (not an AI device).

Summary

{0}------------------------------------------------

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)

General Company Information:

JUL 1 1 2007

Name:Contact:	Axya Medical, Inc.Howard SchrayerRegulatory Affairs Consultant
Address:	100 Cummings CenterSuite 444CBeverly, MA 01915
Telephone:Fax:	(978) 232 - 9997(978) 232 - 9998
Date Prepared:	July 11, 2007
General Device Information:
Product Name:	Axya™ Suture Welding System withAxya Medical Tufflex™ Polyester Suture
Classification:	Nonabsorbable Poly[Ethylene Terephthalate] SutureClass II - Product Code: GAT - 21 CFR § 878.5000Ligature Passing and Knot Tying Instrument - ClassProduct Code: HCF
Predicate Devices:

Axya Suture Welding System and Kit (SWK) [510(k) Number K983108]

Axya Automatic Suturing and Ligating System (ASLS) [510(k) K980988]

Description:

{1}------------------------------------------------

Intended Use (Indications):

The Axya Suture Weld System is indicated for use in securing sutures in soft tissues and for securing ligatures of tubular structures wherever conventional sutures or surgical staples are appropriate. The System may be used in arthroscopic. laparoscopic and open surgical procedures.

Substantial Equivalence:

This submission supports the position that the Axya Suture Welding System and Kit, which may include Tufflex™ polyester suture, is substantially equivalent to the Axya Suture Welding System and Kit (SWK) [510(k) K9831081; and that it is appropriate for its intended application. Suture applicators and suture placement devices which may be used in both endoscopic or traditional open surgical procedures have been classified under 21 CFR 876.1500. These devices are indicated for the placement of sutures to close either traumatic or surgically produced wounds. The device is fabricated from materials with a substantial history of use in medical devices. Both the modified device and the predicate devices secure the suture loop with a weld.

The 510(k) Notice for the system contains references to and summaries of both in vivo and in vitro studies which were conducted to evaluate the safety, efficacy and appropriateness of the suture welding system. Data were presented which demonstrate that sutures placed by means of the suture welding process exhibit "knot strength" characteristics above the USP requirements for the USP suture material tested. These tests confirm that sutures placed with the suture welding technology are equivalent in holding strength (efficacy) to sutures placed with conventional knotting techniques. Additional data were presented that demonstrated that sutures welded in a fluid environment meet USP knot strength requirements. This supports the use of the system in closed endoscopic (arthroscopic) procedures.

The safety of the Suture Welding System was evaluated by placing both welded sutures and manually knotted sutures in bowel tissue of the New Zealand rabbit. Positive (electrocautery) and negative (normal tissue) controls were used in the bowel study. In this animal model there was no unusual adverse histopathologic change seen at the suture implant sites where the suture was welded. The investigators concluded that there was no significant difference in safety of efficacy between the traditional method of suture placement and the technique which replaces manual knot-tying with suture welding. The design of the device protects tissues from potential thermal injury.

No "flux" or "welding rod" is employed and no new chemical entities are introduced or produced in the welding process.

{2}------------------------------------------------

The single-patient-use components of the System and Kit are provided sterile. The sterility processes, the manufacturing process, and the packaging process are validated by the manufacturer.

Conclusions

Axya Medical, Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the Axya Suture Welding System. The materials from which the Axya device is fabricated have an established history of use in medical applications, and devices produced by Axya have undergone appropriate testing and in accordance with applicable FDA guidelines.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Azya Medical, Inc. % Mr. Howard Schrayer Regulatory Affairs Consultant 100 Cummings Center, Suite 444c Beverly, Massachusetts 01915

JUL 1 1 2007

Re: K070253

Trade/Device Name: Axya™ Suture Welding System and Kit Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) Surgical suture Regulatory Class: Class II Product Code: GAT, HCF Dated: July 11, 2007 Received: August 31, 2007

Dear Mr. Schrayer:

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 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.

{4}------------------------------------------------

Page 2 – Mr. Howard Schrayer

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms tetter will and w your to ough finding of substantial equivalence of your device to a legally premarket notification. "The 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miormation 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/indystry/support/index.html.

Sincerely yours,

Mark N. Melkerson

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

Enclosure

{5}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known): K070253

Device Name: Axya™ Suture Welding System and Kit

Indications For Use:

Prescription Use · (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(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 k 020252

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.