(10 days)
Not Found
No
The device description focuses on the physical properties and mechanism of action of a barbed suture, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a barbed monofilament suture used for soft tissue approximation. While it aids in the healing process by holding tissues together, it does not directly treat or cure a disease or condition in the way a therapeutic device typically would (e.g., drug delivery, ablation, stimulation). It serves as a tool for surgical repair rather than a direct therapeutic agent.
No
Explanation: The device is a self-retaining suture system intended for soft tissue approximation, which is a therapeutic function, not a diagnostic one. It does not identify, assess, or monitor a medical condition.
No
The device description clearly describes a physical suture made from a copolymer, available in various lengths and configurations, with barbs. This is a hardware 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 a patient's body.
- Device Description: The device is a "synthetic absorbable monofilament suture" with barbs. This is a physical material used to hold tissue together during healing.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
The Quill™ Self-Retaining System is a surgical device used in vivo (within the living body), not in vitro (in a test tube or lab setting).
N/A
Intended Use / Indications for Use
QuillTM Self-Retaining System (SRS) comprised of MONODERM™ 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)
GAM
Device Description
The Quill™ Self-Retaining System (SRS) comprised of MONODERM™ is a synthetic absorbable monofilament suture prepared from a copolymer of glycolide and e-caprolactone (per 21 CFR 878.4493). 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 0, 2-0 and 3-0. Each suture has bi-directional barbs along the long axis of the suture monofilament.
The Quill™ Self-Retaining System (SRS) comprised of MONODERMIM 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 QuillTM Self-Retaining System (SRS) comprised of MONODERM™ pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quill™ Self-Retaining System (SRS) comprised of MONODERM™ 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)
The Quill™ Self-Retaining System (SRS) comprised of MONODERM™ was compared to MONOCRYL in animal studies to assess the capabilities of barbs to knots in order to maintain wound approximation.
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.
K051609, K052437, K964072, K960653
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
§ 878.4493 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.
0
1. Applicant Contact:
Lois Smart Senior Manager Regulatory Affairs Angiotech Dulles Gateway Center 13921 Park Center Road, Suite 100 Herndon, VA 20171 USA Phone: 443-421-0933 Fax: 703-621-9250 Email: Ismart@aangio.com
K07 2028
Page 1 of 3
AUG - 3 2007
Date Prepared: 07-23-07
| 2. | Name of Device: | Quill™ Self-Retaining System (SRS) comprised of MONODERM™ |
|---|---|---|
| Common Name: | Suture, absorbable, synthetic, polyglycolic acid | |
| Classification Name: | Absorbable poly(glycolide/l-lactide) surgical suture | |
| Regulation 21 CFR 878.4493, Product Code GAM |
3. Identification of device(s) to which the submitted claims equivalence:
The Quill™ Self-Retaining System (SRS) comprised of MONODERM™ is substantially equivalent to the following predicate devices:
- Quill® Synthetic Absorbable Polydioxanone Barbed Suture by Quill Medical, . Inc., 510(k) K051609
- MONODERM™ Synthetic Absorbable Surgical Suture by Surgical . Specialties Corp., 510(k) K052437
- MONOCRYL (Poliglecaprone 25) suture, undyed by ETHICON, Inc., 510(k) . K964072
- MONOCRYL (Poliglecaprone 25) suture, dyed by ETHICON, Inc., 510(k) . K960653
Device Description: 4.
The Quill™ Self-Retaining System (SRS) comprised of MONODERM™ is a synthetic absorbable monofilament suture prepared from a copolymer of glycolide and e-caprolactone (per 21 CFR 878.4493). 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 0, 2-0 and 3-0. Each suture has bi-directional barbs along the long axis of the suture monofilament.
1
K 072028
page 2 of 3
The Quill™ Self-Retaining System (SRS) comprised of MONODERMIM 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 QuillTM Self-Retaining System (SRS) comprised of MONODERM™ pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quill™ Self-Retaining System (SRS) comprised of MONODERM™ breaks, the remaining suture passes will hold the wound edges in approximation.
ડ. Intended Use of the Device:
QuillTM Self-Retaining System (SRS) comprised of MONODERM™ 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.
Indication for Use and Technologv Comparison:
The Quill™ Self-Retaining System (SRS) comprised of MONODERM™ 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 MONODERM™ was compared to MONOCRYL in animal studies to assess the capabilities of barbs to knots in order to maintain wound approximation.
Material Comparison:
The Quill™ Self-Retaining System (SRS) comprised of MONODERM™ is equivalent to the MONODERM™ Synthetic Absorbable Surgical Suture manufactured by Surgical Specialties Corp. as identical materials (fiber-needles & packaging materials) and sterilization method/sterilization cycle is utilized. In addition, the MONODERM™ Synthetic Absorbable Surgical Suture has an intended use of soft tissue approximation
2
| | Quill™ SRS
comprised of
MONODERM
510(k) TBD | Synthetic
Absorbable
PDO Barbed
Sutures,
K051609 | MONODERM
K052437 | MONOCRYL
undyed,
K964072 | MONOCRYL
dyed,
K960653 |
|---------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------|
| Product Code | GAM | Different - NEW | Identical | Identical | Identical |
| Suture
Characteristic | Synthetic Absorbable
Monofilament | Identical | Identical | Identical | Identical |
| Intended Use | Soft tissue
approximation | Identical | Identical | Identical | Identical |
| Technique of
Deployment | Attached needles | Identical | Identical | Identical | Identical |
| Technological
Characteristic | Bi-directional barbs
along the long axis of
the suture
monofilament | Identical | Different -Utilizes
knots to secure the
suture | Different -
Utilizes knots to
secure the suture | Different -
Utilizes knots to
secure the suture |
| Material | PGA-PCL | Different -
Polydioxanone | Identical | Similar -
Poliglecaprone
25 | Similar -
Poliglecaprone
25 |
| Sterilization | EO | Identical | Identical | Identical | Identical |
| Packaging | Device wound onto
inner support card,
within a foil pouch
within a poly/tyvek
pouch | Identical | Identical | Identical | Identical |
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 MONODERM™ and the above mentioned predicate devices do 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, function and intended use discussed herein, Angiotech believes the Quill™ Self-Retaining System (SRS) comprised of MONODERM™ 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 features a stylized eagle or bird-like symbol composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG -3 2007
Angiotech % Lois Smart Regulatory Affairs Manager 100 Dennis Drive Reading, Pennsylvania 19606
Re: K072028
Trade/Device Name: Quill" Self-Retaining System (SRS) comprised of MONODERM™ Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/Llactide) surgical suture Regulatory Class: II Product Code: GAM Dated: July 23, 2007 Received: July 24, 2007
Dear Lois Smart:
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 - Lois Smart
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.
Sincerelv vo Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4 - Indications for Use Statement
510k number if known:
K0720
Device Name: QuillTM Self-Retaining System (SRS) comprised of MONODERMTM
Indications for Use:
Quill™ Self-Retaining System (SRS) comprised of MONODERM™ is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Prescription Use V (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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number