(17 days)
Quill™ Self-Retaining System (SRS) comprised of PDO is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The Quill™ Self-Retaining System (SRS) comprised of PDO is a synthetic absorbable suture available in various suture lengths and needle configurations in USP Sizes 3-0 and 4-0. Each suture has bi-directional barbs along the long axis of the suture strand. Barbs allow for tissue approximation without the need to tie surgical knots.
Quill™ SRS is comprised of dyed (D&C Violet No. 2 per 21 CFR 74.3602) polyester [poly (p-dioxanone)], the empirical molecular formula of which is (C4H6O3)x. Polydioxanone polymer has been found to be nonantigenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.
As with interrupted sutures, if the Quill™ Self-Retaining System (SRS) comprised of PDO breaks, the remaining suture passes will hold the wound edges in approximation.
The provided document is a 510(k) premarket notification for a medical device (Quill™ Self-Retaining System (SRS) comprised of PDO, a surgical suture). This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a new, high-risk device might.
The document does not include information about acceptance criteria or a study that rigorously proves the device meets specific performance criteria in the context of AI/ML or a novel technology requiring extensive clinical trials with statistical endpoints. Instead, it relies on demonstrating equivalence to existing, approved devices.
Therefore, I cannot directly extract most of the requested information, which pertains to a different type of device evaluation study (e.g., AI/MRMC study, standalone performance, ground truth establishment, training set size).
However, I can provide the limited information available from the document:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in a quantitative, statistical sense for this device. Instead, it argues for "substantial equivalence" based on qualitative comparisons and an animal study. The "performance" is implicitly deemed equivalent to the predicate devices.
| Characteristic | Quill™ SRS comprised of PDO (Reported Performance/Characteristic) | Predicate Devices (Implied Acceptance) |
|---|---|---|
| Suture Characteristic | Synthetic Absorbable PDO | Identical (Synthetic Absorbable PDO) |
| Indication for Use | Soft tissue approximation | Identical (Soft tissue approximation) |
| Technique of Deployment | Attached needles | Identical (Attached needles) |
| Technological Characteristic | Bi-directional barbs along the long axis of the suture monofilament | Identical (for Quill® Predicate), Different (for PDS II Predicate) |
| Material | PDO | Identical (PDO) |
| Sterilization | EtO | Identical (EtO) |
| Packaging | Device wound onto inner support card, within a foil pouch within a poly/tyvek pouch | Identical (for Quill® Predicate), Similar (for PDS II Predicate) |
| Functional Equivalence | Capabilities of the barbs to maintain wound approximation (animal study) | Capabilities of barbs/knots to maintain wound approximation (predicates) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "animal studies" to assess the capabilities of the barbs.
- Sample Size: Not specified.
- Data Provenance: "Animal studies." No country of origin or retrospective/prospective nature is specified, but animal studies are typically prospective.
3. 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)
Not applicable. The document describes animal studies, not human-read diagnostic studies involving experts for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication pertains to human expert interpretation of data, which is not described.
5. 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
Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the animal studies, the "ground truth" would be the observed wound approximation over time, likely assessed directly by the researchers or veterinary professionals involved in the study.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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K071989
page 1 of 3
1. Applicant Contact:
Kevin Bentley Director of QA & RA Angiotech 336 Summit Point Drive Henrietta. NY 14467 USA Phone: 585-321-8613 Fax: 585-321-1575 Email: kbentley(@angio.com
AUG -6 2007
Date Prepared: July 19, 2007
Quill™ Self-Retaining System (SRS) comprised of PDO 2. Name of Device: Common Name: Surgical suture, absorbable, Polydioxanone synthetic Classification Name: Absorbable Polydioxanone surgical suture Regulation 21 CFR 878.4840. Product Code NEW
Identification of device(s) to which the submitted claims equivalence: 3.
The Quill™ Self-Retaining System (SRS) comprised of PDO is substantially equivalent to the following predicate device:
- Quill™ Synthetic Absorbable Polydioxanone Barbed Suture by Quill Medical, . Inc., 510(k) K051609
- . PDS II Synthetic Absorbable Surgical Suture by Ethicon, Inc. Docket no. 99P-2589.
Device Description: 4.
The Quill™ Self-Retaining System (SRS) comprised of PDO is a synthetic absorbable suture available in various suture lengths and needle configurations in USP Sizes 3-0 and 4-0. Each suture has bi-directional barbs along the long axis of the suture strand. Barbs allow for tissue approximation without the need to tie surgical knots.
Quill™ SRS is comprised of dyed (D&C Violet No. 2 per 21 CFR 74.3602) polyester [poly (p-dioxanone)], the empirical molecular formula of which is (C4H6O3)x. Polydioxanone polymer has been found to be nonantigenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.
As with interrupted sutures, if the Quill™ Self-Retaining System (SRS) comprised of PDO breaks, the remaining suture passes will hold the wound edges in approximation.
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K071989
page 2 of 3
5. Intended Use of the Device:
Quill" Self-Retaining System (SRS) comprised of PDO is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
6. Characteristics of the device in comparison to those of the predicate devices
Indication for Use and Technology Comparison:
The Quill™ Self-Retaining System (SRS) comprised of PDO is equivalent to the Quill® Synthetic Absorbable Polydioxanone Barbed Suture in its intended use of soft tissue approximation where use of an absorbable suture is appropriate and the technology of using barbs instead of knots to hold the tissue in approximation. The Quill™ Self-Retaining System (SRS) comprised of PDO and the Ethicon PDS II were used in animal studies to assess the capabilities of the barbs to maintain wound approximation as compared to knots.
Material Comparison:
The Quill™ Self-Retaining System (SRS) comprised of PDO is materially equivalent to the predicate devices, Quill® Synthetic Absorbable PDO Barbed Suture and PDS II Synthetic Absorbable Surgical Suture. The Quill" Synthetic Absorbable PDO Barbed Suture and the predicate devices contain similar materials (monofilament fiber, needles & packaging materials), with same or similar EtO sterilization methods.
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| QuillTM SRScomprised of PDO | Quill® SyntheticAbsorbablePolydioxanone BarbedSuture, K051609 | PDS II SyntheticAbsorbable SurgicalSuture, Ethicon, Inc.Docket 99P-5589 | |
|---|---|---|---|
| Product Code | NEW | NEW | NEW |
| Suture Characteristic | Synthetic Absorbable PDO | Identical | Identical |
| Indication for Use | Soft tissue approximation | Identical | Identical |
| Technique ofDeployment | Attached needles | Identical | Identical |
| TechnologicalCharacteristic | Bi-directional barbs alongthe long axis of the suturemonofilament | Identical | Different |
| Material | PDO | Identical | Identical |
| Sterilization | EtO | Identical | Identical |
| Packaging | Device wound onto innersupport card, within a foilpouch within a poly/tyvekpouch | Identical | Similar |
The comparison of the predicate devices to the new device is summarized below:
7. Safety and Performance:
The difference between the Quill™ Self-Retaining System (SRS) comprised of PDO and the above mentioned predicate devices does not raise any questions regarding the safety and effectiveness of the device. The device, as designed, is as safe and effective as its predicate devices.
Conclusion 8.
Based on the design, material, performance specification and indications for use discussed herein, Angiotech believes the Quill™ Self-Retaining System (SRS) comprised of PDO is substantially equivalent to predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling a bird or a wave pattern. Encircling the design is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2007
Angiotech % Kevin Bentley, RAC Director of QA & RA 100 Dennis Drive Reading, Pennsylvania 19606
Re: K071989
Trade/Device Name: Quil!" Self-Retaining System (SRS comprised of PDO Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: II Product Code: NEW Dated: July 19, 2007 Received: July 20, 2007
Dear Mr. Bentley:
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. Ilsting 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 -- Kevin Bentley, RAC
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 (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 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 A. Milke
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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Section 4 - Indications for Use Statement
510k number if known: K071989
1
Quill™ Self-Retaining System (SRS) comprised of PDO Device Name:
Indications for Use:
Quill™ Self-Retaining System (SRS) comprised of PDO is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
ﻢ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mule M. Mellem
K0 7 1989
(Division Sign-Off) (Division of General, Restorative, Division of Neurological Devices
510(k) Number_
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.