(166 days)
Not Found
No
The description focuses on a mechanical process (welding) for securing sutures and does not mention any computational or data-driven decision-making processes characteristic of AI/ML.
No
The device is used for securing sutures and ligatures, which supports surgical procedures but does not directly diagnose, treat, or prevent disease.
No
Explanation: The device is described as a "Suture Welding System" used for securing sutures, which is a surgical tool, not a diagnostic one. Its purpose is to perform a surgical action, not to identify or assess a medical condition.
No
The device description explicitly states it is a "fully disposable singlepatient-use hand-piece with an internal (battery) power supply/controller," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to secure sutures in soft tissues and ligatures of tubular structures within the body during surgical procedures. This is a direct surgical intervention on a patient.
- Device Description: The device is a hand-piece used to perform a surgical task (suture welding).
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. This device does not perform any such analysis.
- Performance Studies: The performance studies described involve in vivo (animal) studies and in vitro studies evaluating the mechanical strength of the welded sutures, not diagnostic information derived from patient samples.
Therefore, the Axya Suture Welding System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GAT, HCF
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.
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)
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.
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.
Not Found
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
§ 878.5000 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.
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 Schrayer
Regulatory Affairs Consultant |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 100 Cummings Center
Suite 444C
Beverly, MA 01915 |
| Telephone:
Fax: | (978) 232 - 9997
(978) 232 - 9998 |
| Date Prepared: | July 11, 2007 |
| General Device Information: | |
| Product Name: | Axya™ Suture Welding System with
Axya Medical Tufflex™ Polyester Suture |
| Classification: | Nonabsorbable Poly[Ethylene Terephthalate] Suture
Class II - Product Code: GAT - 21 CFR § 878.5000
Ligature Passing and Knot Tying Instrument - Class
Product 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:
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.
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.
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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:
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.
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