(11 days)
Not Found
No
The description focuses on the physical properties and mechanical function of a barbed suture, with no mention of AI or ML.
No.
The device is a resorbable barbed suture used for soft tissue approximation, which falls under surgical tools rather than a device for treating a disease or health condition.
No.
The Quill™ Self-Retaining System (SRS) is a self-retaining absorbable suture used for soft tissue approximation, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a synthetic absorbable monofilament suture with barbs, which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue approximation where use of an absorbable suture is appropriate." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a surgical suture with barbs designed to hold tissue together. This is a physical device used in surgery.
- 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, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
Quill™ Self-Retaining System (SRS) comprised of PDO are indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Product codes (comma separated list FDA assigned to the subject device)
NEW
Device Description
The Quill™ Self-Retaining System (SRS) comprised of PDO is a synthetic absorbable monofilament suture comprised of polyester [poly (p-dioxanone)] per 21 CFR 878.4840. It is available sterile, dyed violet (D&C Violet No. 2 per 21 CFR 74.3602) or undyed (beige) in various suture lengths and needle configurations in USP Sizes 3-0. Each suture has bi-directional barbs along the long axis of the suture monofilament.
The Quill™ Self-Retaining System (SRS) comprised of PDO approximates tissue by using the opposing barbs on the suture surface to imbed in the tissues after the surgeon precisely places the suture within the tissues. Each Quill™ Self-Retaining System (SRS) comprised of PDO pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the QuillTM Self-Retaining System (SRS) comprised of PDO breaks, the remaining suture passes will hold the wound edges in approximation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue
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)
Not Found
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
§ 878.4840 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.
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KO 86680
Page 1 of 3
1. Applicant Contact:
Trudy Estridge Director, Regulatory Affairs Angiotech Dulles Gateway Center 13921 Park Center Road, Suite 100 Herndon, VA 20171 USA Phone: 703-796-8927 Fax: 703-673-0061 Email: testridge@angio.com
MAR 2 1 2008
Date Prepared: 03-07-08
| | Name of Device: | Quill™ Self-Retaining System (SRS) comprised of PDO
(Polydioxanone) |
|--|----------------------|-----------------------------------------------------------------------------------------|
| | Common Name: | Suture, Surgical, Absorbable, Polydioxanone |
| | 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 Barbed Suture by Quill Medical Corporation, . 510(k) K051609
- Quill™ Self-Retaining System (SRS) comprised of PDO (Polydioxanone) by ● Surgical Specialties Corporation dba Angiotech, 510(k) K071989
4. Device Description:
The Quill™ Self-Retaining System (SRS) comprised of PDO is a synthetic absorbable monofilament suture comprised of polyester [poly (p-dioxanone)] per 21 CFR 878.4840. It is available sterile, dyed violet (D&C Violet No. 2 per 21 CFR 74.3602) or undyed (beige) in various suture lengths and needle configurations in USP Sizes 3-0. Each suture has bi-directional barbs along the long axis of the suture monofilament.
The Quill™ Self-Retaining System (SRS) comprised of PDO approximates tissue by using the opposing barbs on the suture surface to imbed in the tissues after the surgeon precisely places the suture within the tissues. Each Quill™ Self-Retaining System (SRS) comprised of PDO pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the QuillTM Self-Retaining System (SRS) comprised of PDO breaks, the remaining suture passes will hold the wound edges in approximation.
1
Image /page/1/Picture/1 description: The image shows handwritten text on a white background. The text includes the alphanumeric string "K080680" on the first line. The second line reads "page 2 of 3", indicating it is page 2 of a 3-page document. The handwriting style appears cursive and slightly irregular.
ડ. Intended Use of the Device:
QuillTM Self-Retaining System (SRS) comprised of PDO are indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Characteristics of the device in comparison to those of the predicate device(s) 6.
The Quill™ Self-Retaining System (SRS) comprised of PDO is equivalent to the predicate devices 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 device modification is to decrease the spacing between the barbs on the suture length thereby increasing the number of barbs per linear length to increase tissue holding strength.
The comparison of the new device to the predicate devices is summarized below:
| | Quill TM SRS comprised
of PDO
510(k) TBD | Quill® Synthetic
Absorbable Barbed Suture
510(k) K051609 | Quill TM SRS comprised of
PDO, 510(k) K071989 |
|---------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------|
| Product Code | NEW | Identical | Identical |
| Suture
Characteristic | Synthetic Absorbable
Monofilament | Identical | Identical |
| Intended Use | Soft tissue approximation | Identical | Identical |
| Technique of
Deployment | Attached needles | Identical | Identical |
| Technological
Characteristic | Bi-directional barbs along
the long axis of the suture
monofilament | Identical | Identical |
| Material | Polydioxanone | Identical | Identical |
| Sterilization | EO | Identical | Identical |
| Packaging | Device wound onto inner
support card, within a foil
pouch within a poly/tyvek
pouch | Identical | Identical |
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.
2
Image /page/2/Picture/1 description: The image shows handwritten text on a white background. The text at the top reads "K0 80680". Below that, the text reads "Page 3 of 3". The handwriting is cursive and slightly uneven.
8. Conclusion
Based on the design, material, function and intended 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.
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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2008
Surgical Specialties Corporation % Angiotech Trudy D. Estridge, Ph.D. 13921 Park Center Road, Suite 100 Herndon, Virginia 21071
Re: K080680
Trade/Device Name: Quill™ Self-Retaining System (SRS) comprised of PDO Regulation Code: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: II Product Code: NEW Dated: March 7, 2008 Received: March 10, 2008
Dear Dr. Estridge:
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 - Trudy D. Estridge, Ph.D.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 N Mulhausen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Attachment F - Indications for Use Statement
510k number if known:
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 _____________________________________________________________________________________________________________________________________________________________ (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Melkum
Division of General, Restorative. and Neurological Devices
510(k) Number K08 0680