(74 days)
VISORB Swift™ Absorbable Surgical Sutures are indicated for use in general soft tissue approximations, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue approximation.
Not Found
The provided text describes a 510(k) summary for the VISORB Swift™ absorbable surgical suture. The primary claim for acceptance is based on meeting or exceeding performance requirements set forth by USP 25, and substantial equivalence to predicate devices from Ethicon and B/BRAUN.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| USP 25 Performance Requirements | Meets or exceeds USP 25 performance requirements. |
| Equivalency to Predicate Devices (Design, Material Composition, Performance, Intended Use) | Comparison data demonstrates equivalency to Ethicon and B/BRAUN predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for performance testing (e.g., USP 25 testing) or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "comparison data" for equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The evaluation relies on standardized performance metrics (USP 25) and comparative data against predicate devices, rather than an expert consensus ground truth for a specific test set.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of a medical device like a surgical suture, the "ground truth" would be established through physical and chemical testing against established standards (USP 25) and direct comparison with predicate devices, rather than through an adjudication process by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices (e.g., imaging AI) where human readers are directly interacting with the device's output. For a surgical suture, the performance is evaluated through material properties and mechanical strength, not human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not directly applicable to a surgical suture. The device itself is not an "algorithm." Its performance is inherent in its physical and chemical properties. The tests performed (implicitly those required by USP 25) would be "standalone" in the sense that they evaluate the device itself without human interaction beyond conducting the test.
7. The Type of Ground Truth Used
The ground truth used for proving device performance appears to be:
- Standardized Performance Metrics: Specifically, the requirements outlined in USP 25 (United States Pharmacopeia).
- Comparative Data: Performance data compared against legally marketed predicate devices (Ethicon and B/BRAUN) to demonstrate substantial equivalence in design, material composition, performance, and intended use.
8. The Sample Size for the Training Set
This information is not provided and is not applicable in the context of this device. Surgical sutures are physical devices, not machine learning algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for the reasons stated in point 8.
{0}------------------------------------------------
JAN 1 7 2003
KO23710
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR 807.92.
| Device Name: | |
|---|---|
| Trade Name: | VISORB Swift™ |
| Common Names: | Absorbable suture, synthetic absorbable suture, PGA suture |
| Classification Names: | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Establishment Name, Contact & Registration Number: | |
| Name: | C.P. Medical, Inc. |
| 836 N.E. 24th. Ave | |
| Portland, Oregon 97232 | |
| Tele: (503) 232-1555 | |
| Fax: (503) 230-9993 | |
| Contact: | Mary Ann Greenawalt (VP Legal & Regulatory) |
| or | |
| Sue Ridge (Technical Writer - Regulatory) | |
| Classification: | |
| Device Class: | Class 11 |
| Classification Panel: | General & Plastic Surgery |
| Product Code: | 79GAM |
| Intended Use: | VISORB Swift™ Absorbable Surgical Sutures are indicated for use in general soft tissue approximations, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue approximation. |
| Equivalent Predicated Device: | |
| VISORB Swift™ synthetic absorbable suture is substantially equivalent to the predicate devices marketed by Ethicon and B/BRAUN. The comparison data demonstrates that equivalency can be drawn with respect to the design, material composition, performance and intended use. | |
| Performance Standard: |
VISORB Swift™ meets or exceeds the performance requirements set forth by USP 25.
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three figures in profile facing right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2003
CP Medical Mary Ann Greenawalt Legal and Regulatory Affairs 836 N.E. 24" Avenue Portland, Oregon 97232
Re: K023710
Trade/Device Name: VISORB Swift™ Regulation Number: 878.4840 Regulation Name: Synthetic, absorbable suture, polyglycolic acid Regulatory Class: Class II Product Code: GAM Dated: November 1, 2002 Received: November 4, 2002
Dear Ms. Greenawalt:
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.
{2}------------------------------------------------
Page 2 – Ms. Mary Ann Greenawalt
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Page 1 of 1 .
510(k) Number: K02-3710
Device Name(s): VISORB Swift™
Intended Use(s) of the Device:
General soft tissue approximation; including use in Ophthalmic surgery, but not for use in Cardiovascular and Neurological tissue approximation.
Miriam C. Provost
ivision Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number K023710
Please do not write below this line - continue on another page if necessary Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| ------------------ | ---------------------------------------------------- |
Over-The-Counter Use _______
(per 21 CFR 801.109)
Or
(Optional format 1-2-96)
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.