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.

AI/ML Overview

The Quill® Nonabsorbable Nylon Barbed Suture is a medical device and doesn't involve AI/ML. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, expert qualifications, and MRMC studies, are not applicable.

However, based on the provided 510(k) summary, here's an analysis of its acceptance criteria and how the device meets them, focusing on the equivalence established for this type of medical device:

Acceptance Criteria and Device Performance

The acceptance criteria for the Quill® Nonabsorbable Nylon Barbed Suture are established through demonstrating substantial equivalence to legally marketed predicate devices. This equivalence is based on:

Identical Intended Use: Soft tissue approximation, excluding closure of the epidermis.
Similar Technological Characteristics: Using barbs to secure tissue, obviating the need for knots.
Identical Material: Nylon.
Identical Sterilization and Packaging Methods.

The following table summarizes the comparison:

Characteristic	Acceptance Criterion (Based on Predicate Devices)	Reported Device Performance (Quill® Nonabsorbable Nylon Barbed Suture)	Meets Acceptance Criterion?
Product Code	GAR (for Nylon Sutures) or GAW (for Polypropylene Barbed Sutures)	GAR (Identical to Nylon Predicates)	Yes
Suture Characteristic	Nonabsorbable Monofilament	Nonabsorbable Monofilament (Identical)	Yes
Intended Use	Soft tissue approximation (with applicable Warnings)	Soft tissue approximation (with applicable Warnings) (Identical)	Yes
Technique of Deployment	Attached needles	Attached needles (Identical)	Yes
Technological Characteristic	Bi-directional barbs along the long axis of the suture monofilament (for barbed suture predicate) OR Suture monofilament that utilizes knots to secure the suture (for traditional nylon suture predicates)	Bi-directional barbs along the long axis of the suture monofilament (Identical to barbed suture predicate)	Yes
Material	Nylon (for nylon suture predicates) OR Polypropylene (for barbed suture predicate)	Nylon (Identical to nylon suture predicates)	Yes
Sterilization	EO (Ethylene Oxide)	EO (Identical)	Yes
Packaging	Device wound onto cardboard inner support card and packaged in a Tyvek pouch	Device wound onto cardboard inner support card and packaged in a Tyvek pouch (Identical)	Yes

Study Information (Based on 510(k) Summary)

For non-AI medical devices following the 510(k) pathway, "studies" often refer to comparative analyses, biocompatibility testing (if new materials), and mechanical testing, rather than clinical efficacy trials akin to drug approval or AI model validation studies. The provided document focuses entirely on demonstrating substantial equivalence.

Here's an assessment based on the available information:

Sample size used for the test set and the data provenance: Not applicable to this type of device submission. The "test set" here is primarily the comparison against predicate device characteristics.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for equivalence is established by regulatory standards and existing device classifications.
Adjudication method: Not applicable.
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, as this is a physical medical device, not an AI/ML algorithm.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used:
- Regulatory Standards and Predicate Device Data: The "ground truth" for this submission is based on the characteristics, safety, and effectiveness profiles of the legally marketed predicate devices and established regulatory requirements for nonabsorbable surgical sutures (21 CFR 878.5020). The predicates have already demonstrated safety and effectiveness through their prior market clearance.
The sample size for the training set: Not applicable, as this is not an AI/ML algorithm device.
How the ground truth for the training set was established: Not applicable.

Overall Conclusion from the 510(k) Summary:

The manufacturer, Quill Medical, believes the Quill® Nonabsorbable Nylon Barbed Suture is substantially equivalent to the identified predicate devices based on its design, material, function, and intended use. The key arguments for equivalence are:

Identical intended use (soft tissue approximation) to all predicates.
Identical barbed technology for tissue approximation as the Quill® Nonabsorbable Polypropylene Barbed Suture (K052373).
Identical material (Nylon) to the Nonabsorbable Nylon Surgical Sutures by Surgical Specialties Corp. (K930825) and GramsMed, LLC (K003000), which are well-established materials known to be biocompatible and safe for medical applications.

The FDA's letter (K052900) confirms their review of the submission and their determination that the device is substantially equivalent to legally marketed predicate devices, allowing the device to be marketed. This decision indicates that the FDA agreed with the manufacturer's assessment that the device meets the necessary acceptance criteria through its comparison to the predicates and does not raise new questions of safety or effectiveness.

Summary

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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.
- Nonabsorbable Nylon Surgical Sutures by Surgical Specialties Corp., 제 510(k) K930825
- I Grams Nylon Nonabsorbable Suture by GramsMed, LLC, 510(k) K003000
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:

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K052900

2/4

Section 5 - 510(k) Summary (continued)

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.

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K052900 3/4

Section 5 - 510(k) Summary (continued)

	Quill®NonabsorbableNylon BarbedSutures,510(k) TBD	Surgical SpecialtiesCorp.NonabsorbableNylon SurgicalSutures,510(k) K930825	GramsMed,LLC, GramsNylonNonabsorbableSutures, 510(k)K003000	Quill®NonabsorbablePolypropyleneBarbed Sutures,510(k) K052373
Product Code	Identical - GAR	Identical - GAR	Identical - GAR	Different - GAW
SutureCharacteristic	Identical -NonabsorbableMonofilament	Identical -NonabsorbableMonofilament	Identical -NonabsorbableMonofilament	Identical -NonabsorbableMonofilament
Intended Use	Identical - Soft tissueapproximation withapplicable Warnings	Identical - Soft tissueapproximation	Identical - Softtissueapproximation	Identical - Softtissue approximationwith applicableWarnings
Technique ofDeployment	Identical -- Attachedneedles	Identical - Attachedneedles	Identical -Attached needles	Identical - Attachedneedles
TechnologicalCharacteristic	Identical - Bi-directional barbs alongthe long axis of thesuture monofilament	Different - Suturemonofilament thatutilizes knots to securethe suture	Different - Suturemonofilament thatutilizes knots tosecure the suture	Identical - Bi-directional barbsalong the long axisof the suturemonofilament
Material	Identical - Nylon(cleared per K930825or K003000)	Identical - Nylon	Identical - Nylon	Different -Polypropylene
Sterilization	Identical - EO	Identical - EO	Identical - EO	Identical - EO
Packaging	Identical - Devicewound onto cardboardinner support card andpackaged in a Tyvekpouch)	Identical - Devicewound onto cardboardinner support card andpackaged in a Tyvekpouch)	Identical - Devicewound ontocardboard innersupport card andpackaged in aTyvek pouch)	Identical - Devicewound ontocardboard innersupport card andpackaged in a Tyvekpouch)

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.

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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.

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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.

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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

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K052900

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

Regulation Number and Section

§ 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.