(84 days)
No
The 510(k) summary describes a mechanical device that uses ultrasonic energy for welding sutures. There is no mention of AI, ML, image processing, or data training/testing, which are typical indicators of AI/ML technology.
No.
The device is used for securing sutures in soft tissues and ligatures of tubular structures, which are supportive functions for surgical procedures rather than directly treating a disease or condition.
No
This device, the Axya Suture Welding System and Kit (SWK), is indicated for securing sutures and ligatures in soft tissues, essentially functioning as a surgical tool for wound closure. Its purpose is to physically secure materials during surgery, not to diagnose conditions or provide information about a patient's health status.
No
The device description clearly details physical components like suture applicators, suture placement devices, and an ultrasonic energy source (generator), indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for securing sutures in soft tissues and ligating tubular structures during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The description details a surgical system that uses ultrasonic energy to weld sutures. It discusses the materials, sterilization, and comparison to other surgical suturing and ligating devices.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The Suture Welding System and Kit is indicated for securing synthetic monofilament sutures in soft tissues and for securing ligatures of tubular structures wherever conventional monofilament sutures or surgical staples are appropriate. The SWK is indicated for use in both traditional open surgery and endoscopic surgical procedures.
Product codes
GAW
Device Description
The Axya Suture Welding System and Kit (SWK) is designed for the placement of sutures in soft tissue to close either traumatic or surgically produced wounds. It secures the suture loop with an ultrasonic weld. The device includes a suture delivery system and uses an ultrasonic energy source to weld and secure the suture loop. The suture material is heated and welded by friction, forming the weld by melting and fusing the polymer. No "flux" or "welding rod" is employed, and no new chemical entities are introduced or produced in the welding process. The AxyaWeld Sleeve design prevents the heated area of the suture from coming into direct contact with tissues. The device is fabricated from materials with a substantial history of use in medical devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, tubular structures
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)
In vitro studies:
- Evaluation of safety, efficacy and appropriateness of the suture welding system.
- Strength tests demonstrated that sutures placed by means of the suture welding process exhibit "knot strength" characteristics substantially above the USP requirements for the respective sizes and types of suture materials tested.
- These tests confirmed that synthetic monofilament sutures placed with the ultrasonic suture welding technology are equivalent in holding strength (efficacy) to sutures placed with conventional knotting techniques.
- Additional data confirmed that synthetic monofilament sutures secured by weld formed with the AxyaWeld Tips have equivalent knot strength to sutures welded with the predicate AxyaStitch Cartridge.
- For synthetic absorbable sutures (Maxon™), strength was tested at baseline and at one-week intervals over seven weeks following immersion in a constant temperature bath maintained at 98.5 degrees F. The strength loss curves followed the profile described in the suture manufacturer's package insert and exceeded the predicted strength retention requirements based on USP requirements for knot strength of synthetic absorbable suture. This showed that the welding process had no deleterious effect on the strength retention profile.
In vivo studies:
- Safety Study: Welded sutures and manually knotted sutures were placed in the dorsal skin and in bowel tissue of New Zealand rabbits.
- Controls: Positive (electrocautery contact) and negative (normal tissue) controls were used in the bowel study.
- Results: In both animal models, there was no histopathologic change seen at the suture implant sites where the suture was sealed with ultrasonic energy.
- Conclusion: No significant difference in safety or efficacy between the traditional method of suture placement and the technique which includes replacement of manual knot-tying with suture welding.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.
0
SUMMARY OF SAFETY AND EFFECTIVENESS
This submission supports the position that the Axya Suture Welding System and Kit (SWK) is substantially equivalent in design and function to the Axya Suturing and Ligating System (ASLS) {510(k) K980988] and the Endo-Judge disposable suture placement system developed by Synergistic Medical Technologies and marketed by Ethicon Endosurgery [510(k) K932591], 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 in soft tissue to close either traumatic or surgically produced wounds. The SWK is fabricated from materials with a substantial history of use in medical devices. Both the SWK and the predicate device secure the suture loop with an ultrasonic weld.
The 510(k) Notice for the predicate system contains summaries of both in vivo and in vitro studies which were conducted to evaluate the safety, efficacy and appropriateness of the suture welding system. These data are applicable to the Suture Welding System because the design and components of the welding mechanism are the same as those used in the ASLS that was previously cleared for marketing. Data were presented which demonstrate that sutures placed by means of the suture welding process exhibit "knot strength" characteristics substantially above the USP requirements for the respective sizes and types of suture materials tested. These tests confirm that the synthetic monofilament sutures placed with the ultrasonic suture welding technology are equivalent in holding strength (efficacy) to sutures placed with conventional knotting techniques. Additional data presented confirm that synthetic monofilament sutures secured by weld formed with the AxyaWeld Tips have equivalent knot strength to sutures welded with the predicate AxyaStitch Cartridge.
In previously submitted efficacy studies of synthetic absorbable sutures (Maxon™), these materials were tested for strength at baseline and at one-week intervals over seven weeks following immersion in a constant temperature bath maintained at 98.5 degrees F. The strength loss curves for this synthetic absorbable suture follow the profile described in the suture manufacturer's package insert and exceed the predicted strength retention requirements based on USP requirements for knot strength of synthetic absorbable suture. This demonstrates that the welding process had no deleterious effect on the strength retention profile of the synthetic absorbable sutures.
The safety of the suture delivery system was evaluated by placing both welded sutures and manually knotted sutures in the dorsal skin and in bowel tissue of New Zealand rabbits. Positive (electrocautery contact) and negative (normal tissue) controls were used in the bowel study. In both animal models there was no histopathologic change seen at the suture implant sites where the suture was sealed with ultrasonic energy. The investigators concluded that there was no significant difference in safety of efficacy between the traditional method of suture placement and the technique which includes replacement of manual knot-tving with suture welding. The design of the AxyaWeld Sleeve also prevents the heated area of suture from coming into direct contact with tissues.
Image /page/0/Picture/7 description: The image contains the number 33. The number is written in a simple, sans-serif font. The digits are bold and black against a white background, making them easily readable.
1
The ultrasonic energy source used to weld and secure the suture loop is the same generator used for the Automatic Suturing and Ligating System and is similar to the energy source used in the UltraCision Harmonic Scalpel [510(k) K895252].
Because of design features of the SWK, no portion of the ultrasonic generator comes into contact with human tissues. Because of this, there is virtually no risk of causing a thermal injury to the patient. The suture material is heated and welded by friction and the weld is formed by melting and fusing the polymer. No "flux" or "welding rod" is employed and no new chemical entities are introduced or produced in the welding process.
The Axya Suture Welding System and Kit are sterilized by exposure to gamma irradiation at 2.5 Mrads which provides a sterility assurance level of at least 10° or, alternatively, by means of an ethylene oxide gas sterilization process which also provides a SAL of 10°. The sterility process selected is dictated by the type of suture included with a given product configuration. These sterility processes, the manufacturing process, and the packaging process are validated by the manufacturer.
Axya Medical, Inc. believes that the information provided establishes that similar legally marketed and pre-enactment devices have been used for the same types of clinical applications as the Axya Suture Welding System and Kit. The materials from which the Axya device is fabricated have an established history of use in medical applications, and the specific materials used by Axya have been thoroughly tested in accordance with applicable FDA guidelines.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the top of the image. The logo is simple and iconic, representing the department's mission to protect the health of all Americans.
NOV 27 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Howard L. Schraver Axya Medical, Inc. 100 Cummings Center Suite 444C Beverly, Massachusetts 01915
Re: K983108 Trade Name: Axya, Suture Welding System and Kit, (SWK) Regulatory Class: II Product Code: GAW Dated: September 03, 1998 Received: September 04, 1998
Dear Mr. Schrayer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act). You may, therefore, market your device subject to the general control provisions of the Federal Food. Drug. and Cosmetic Act (Act). Please note: If you purchase your device components in bulk (i.e., unfinished) and further process them (e.g., sterilize), you must submit a new 510(k) before including these components in your kit/tray. The general control provisions of the Act include requirements for 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 (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Howard L. Schrayer
FDA notes that your device will contain sutures for which you have provided evidence that the suture characteristics are not altered by the sterilization process used for the device. However, you should be aware of the following additional information regarding the inclusion of a suture as a component of your device:
- The labeling, packaging and method of sterilization of the suture cannot be 1. changed without prior notification, review and clearance by FDA.
- The supplier of the sutures used in your device cannot be changed without 2. prior notification, review and clearance by FDA.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
510(k) Number (if known): _
విష్యాల్యే Device Name: Axya, Suture Welding System and Kit, (SWK)
Indications For Use:
The Suture Welding System and Kit is indicated for securing synthetic monofilament sutures in soft tissues and for securing ligatures of tubular structures wherever conventional monofilament sutures or surgical staples are appropriate. The SWK is indicated for use in both traditional open surgery and endoscopic surgical procedures.
(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 Devices | |
| 510(k) Number | K983108 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)