(45 days)
Not Found
No
The device description and intended use are purely mechanical, describing a barbed suture. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device, Quill® Nonabsorbable Nylon Barbed Sutures, is indicated for soft tissue approximation, which is a supportive function during wound healing rather than a direct therapeutic action on a disease or condition. Therapeutic devices typically treat or alleviate a medical condition.
No
The device is a Quill® Nonabsorbable Nylon Barbed Suture, which is used for soft tissue approximation. Its function is to hold tissues together, not to diagnose a condition.
No
The device description clearly describes a physical medical device (sutures) made of Nylon with barbs, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Quill® Nonabsorbable Nylon Barbed Suture is a surgical suture used to physically approximate soft tissues within the body. It is a physical implant/device used during surgery.
- Intended Use: The intended use is "soft tissue approximation excluding closure of the epidermis," which is a surgical procedure performed directly on the patient's body.
The description clearly indicates a surgical device used in vivo (within the living body), not an in vitro diagnostic test performed on specimens outside the body.
N/A
Intended Use / Indications for Use
Quill® Nonabsorbable Nylon Barbed Sutures are indicated for use in soft tissue approximation excluding closure of the epidermis.
Product codes
GAR
Device Description
The Ouill® Nonabsorbable Nylon Barbed Suture is a monofilament, flexible thread prepared from long chain aliphatic polymers Nylon 6 and Nylon 6,6 (per 21 CFR 878.5020). It is available sterile, dyed black (logwood extract per 21 CFR 73.1410), dyed blue (FD&C Blue No. 2 per 21 CFR 74.3102) or undyed in various suture diameters, lengths and needle configurations in USP Sizes 2, 1, 0, 2-0, 3-0. Each suture has bi-directional barbs along the long axis of the suture monofilament. The Quill® Nonabsorbable Nylon Barbed Sutures approximate tissues 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® Nonabsorbable Nylon Barbed Suture pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quill® Nonabsorbable Nylon Barbed Suture 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; 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
K052900,1/4
NOV 2 8 2005
Section 5 - 510(k) Summary
1. Applicant Contact:
Lois Smart Director, Quality Assurance and Regulatory Affairs Quill Medical, Inc. 2505 Meridian Drive, Suite 150 Research Triangle Park. NC 27713 Phone: 919-806-1961 Fax: 919-806-1953 Email: Ismart@quillmedical.com
Date Prepared:
| 2. | Name of Device: | Quill® Nonabsorbable Nylon Barbed Suture |
|---|---|---|
| Common Name: | Nonabsorbable Nylon Surgical Suture | |
| Classification Name: | Nonabsorbable Nylon Surgical Suture | |
| Regulation 21 CFR 878.5020, Product Code GAR |
3. Identification of device(s) to which the submitted claims equivalence:
The Quill® Nonabsorbable Nylon Barbed Suture is substantially equivalent to the following predicate devices:
- Predicate for Material: a.
- Predicate for Indication for Use based on Technological Characteristics: b.
- Quill® Nonabsorbable Polypropylene Barbed Suture by Quill Medical, 에 Inc., 510(k) K052373
4. Device Description:
The Ouill® Nonabsorbable Nylon Barbed Suture is a monofilament, flexible thread prepared from long chain aliphatic polymers Nylon 6 and Nylon 6,6 (per 21 CFR 878.5020). It is available sterile, dyed black (logwood extract per 21 CFR 73.1410), dyed blue (FD&C Blue No. 2 per 21 CFR 74.3102) or undyed in various suture diameters, lengths and needle configurations in USP Sizes 2, 1, 0, 2-0, 3-0. Each suture has bi-directional barbs along the long axis of the suture monofilament.
1
2/4
Section 5 - 510(k) Summary (continued)
The Quill® Nonabsorbable Nylon Barbed Sutures approximate tissues 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® Nonabsorbable Nylon Barbed Suture pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quill® Nonabsorbable Nylon Barbed Suture breaks, the remaining suture passes will hold the wound edges in approximation.
క. Intended Use of the Device:
Quill® Nonabsorbable Nylon Barbed Sutures are indicated for use in soft tissue approximation excluding closure of the epidermis.
6. Characteristics of the device in comparison to those of the predicate device(s)
Indication for Use and Technology Comparison:
The Quill® Nonabsorbable Nylon Barbed Suture is equivalent to the Ouill® Nonabsorbable Polypropylene Barbed Suture in its intended use of soft tissue approximation and the technology of using barbs instead of knots to hold the tissue in approximation. In addition, the Nonabsorbable Nylon Surgical Suture manufactured by Surgical Specialties Corp. and GramsMed, LLC have an intended use of soft tissue approximation.
Material Comparison:
The Quill® Nonabsorbable Nylon Barbed Suture is equivalent to the Nonabsorbable Nylon Surgical Suture manufactured by Surgical Specialties Corp. and GramsMed, LLC as identical materials (nylon fiber, needles & packaging materials) and sterilization method is utilized.
2
K052900 3/4
Section 5 - 510(k) Summary (continued)
| | Quill®
Nonabsorbable
Nylon Barbed
Sutures,
510(k) TBD | Surgical Specialties
Corp.
Nonabsorbable
Nylon Surgical
Sutures,
510(k) K930825 | GramsMed,
LLC, Grams
Nylon
Nonabsorbable
Sutures, 510(k)
K003000 | Quill®
Nonabsorbable
Polypropylene
Barbed Sutures,
510(k) K052373 |
|---------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Product Code | Identical - GAR | Identical - GAR | Identical - GAR | Different - GAW |
| Suture
Characteristic | Identical -
Nonabsorbable
Monofilament | Identical -
Nonabsorbable
Monofilament | Identical -
Nonabsorbable
Monofilament | Identical -
Nonabsorbable
Monofilament |
| Intended Use | Identical - Soft tissue
approximation with
applicable Warnings | Identical - Soft tissue
approximation | Identical - Soft
tissue
approximation | Identical - Soft
tissue approximation
with applicable
Warnings |
| Technique of
Deployment | Identical -- Attached
needles | Identical - Attached
needles | Identical -
Attached needles | Identical - Attached
needles |
| Technological
Characteristic | Identical - Bi-
directional barbs along
the long axis of the
suture monofilament | Different - Suture
monofilament that
utilizes knots to secure
the suture | Different - Suture
monofilament that
utilizes knots to
secure the suture | Identical - Bi-
directional barbs
along the long axis
of the suture
monofilament |
| Material | Identical - Nylon
(cleared per K930825
or K003000) | Identical - Nylon | Identical - Nylon | Different -
Polypropylene |
| Sterilization | Identical - EO | Identical - EO | Identical - EO | Identical - EO |
| Packaging | Identical - Device
wound onto cardboard
inner support card and
packaged in a Tyvek
pouch) | Identical - Device
wound onto cardboard
inner support card and
packaged in a Tyvek
pouch) | Identical - Device
wound onto
cardboard inner
support card and
packaged in a
Tyvek pouch) | Identical - Device
wound onto
cardboard inner
support card and
packaged in a Tyvek
pouch) |
The comparison of the predicate devices to the new device is summarized below:
7. Safety and Performance:
The difference between the Quill® Nonabsorbable Nylon Barbed Suture and the above mentioned predicate devices do not raise any questions regarding the safety and effectiveness of the barbed suture. The Quill® Nonabsorbable Nylon Barbed Suture employs the same technological characteristics to support the intended use of soft tissue approximation as the Quill® Nonabsorbable Polypropylene Barbed Suture. In addition, nylon (as used in the predicate device by Surgical Specialties Corp. and the predicate device by GramsMed, LLC) is commonly used in medical applications and has proven to be biocompatible. The device, as designed, is as safe and effective as its predicate devices.
3
KOS2904/4
Section 5 - 510(k) Summary (continued)
8. Conclusion
Based on the design, material, function and intended use discussed herein, Quill Medical believes the Quill® Nonabsorbable Nylon Barbed Suture is substantially equivalent to predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
NOV 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lois Smart Director, Quality Assurance and Regulatory Affairs Ouill Medical, Inc. 2505 Meridian Drive, Suite 150 Research Triangle Park, North Carolina 27713
Re: K052900
Trade/Device Name: Quill® Nonabsorbable Nylon Barbed Suture Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polyamide surgical suture Regulatory Class: II Product Code: GAR Dated: October 13, 2005 Received: October 14, 2005
Dear Ms. 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.
5
This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotet notification. The FDA finding of substantial equivalence of your device to a legally premaince nevice 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 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/industry/support/index.html
Sincerely yours,
Barbara Buchup
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Section 4 - Indications for Use Statement
510k number if known:
Quill® Nonabsorbable Nylon Barbed Suture Device Name:
Indications for Use:
Quill® Nonabsorbable Nylon Barbed Sutures are indicated for soft tissue approximation excluding closure of the epidermis.
Prescription Use 2 (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)
Barbara Bonelup for MXM
Division of General, Resto ive, and Neurological Devices
510(k) Number*K052980*
Section 4 Page 1 of 1