The Quill™ Synthetic Absorbable Barbed Suture is made from the polymer, poly(p-dioxanone). It is available in a dyed form (violet) in various suture lengths and needle configurations. The Quill™ Synthetic Absorbable Barbed Suture degrades or dissolves over time in tissues. The Quill™ Synthetic Absorbable Barbed Sutures approximate tissues by using the opposing barbs on the suture surface imbedded in the tissues after the surgeon suture pierces the skin and appropriately places the suture within the tissues. The barbs on the Quill suture form an alternative method than knots in conventional suture for holding the two ends of a suture together.

AI/ML Overview

Here's an analysis of the provided text, outlining acceptance criteria and study details for the Quill™ Synthetic Absorbable Barbed Suture:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (Ethicon PDS II Suture) rather than explicitly listing acceptance criteria with numerical targets. However, the performance metrics used for comparison serve as de facto acceptance criteria for equivalence.

Parameter	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (Quill™ Synthetic Absorbable Barbed Suture)
Material Composition	Poly (p-dioxanone) (matching predicate)	Poly (p-dioxanone)
USP Sizes	9-0 to 2 (predicate range, device is within this range for its available sizes)	2-0 to 2
Oversized Diameter	Yes (matching predicate)	Yes
Tensile Strength Equivalence	Comparable to predicate for specific USP sizes (e.g., Quill Size 2-0 ≅ USP Size 4-0, Quill Size 0 ≅ USP Size 3-0, Quill Size 2 ≅ USP Size 0)	Quill Size 2-0, Quill Size 0, Quill Size 2 (matched to predicate sizes)
Approximation Method	Knots (predicate) - Note: This is a key difference, addressed by clinical equivalency of function.	Barbs
Absorption Profile (% Remaining at Time)	0 months: 100%2 months: ~100%4 months: ~100%6 months: ~26% (Predicate values are the benchmark)	0 months: 100%2 months: ~101%4 months: ~94%6 months: ~18%
Strength Retention Profile (% Strength at Time)	0 week: 100%2 week: ~70%4 week: ~50%6 week: ~25% (Predicate values are the benchmark)	0 week: 100%2 week: ~81%4 week: ~79%6 week: ~42%
Biocompatibility	Non-toxic, non-hemolytic, non-irritating, non-pyrogenic, non-allergenic, non-sensitizing, non-cytotoxic, non-reactive, and biocompatible (matching predicate expectations based on ISO 10993)	Data presented demonstrate that Quill PDO Sutures are non-toxic, non-hemolytic, non-irritating, non-pyrogenic, non-allergenic, non-sensitizing, non-cytotoxic, non-reactive and biocompatible.
In Vivo Tensile Strength Loss	Losing tensile strength during the critical wound healing period (e.g., roughly 30% at 2 weeks, 50% at 4 weeks, 75% at 6 weeks for predicate)	Approximately 20% lost in two weeks; 20% lost in four weeks; 60% lost in six weeks.
Barb Holding Strength	Sufficient to approximate tissues during the critical wound period (predicate does not have barbs, so this is a unique functional criterion for the Quill™ device)	Decreases slightly after implantation, remains relatively constant for approximately four weeks after implantation and retains sufficient tensile strength to approximate tissues during the critical wound period.
Absorption Time	Similar hydrolytic degradation and absorption profile as predicate (e.g., completely absorbed by 6 months).	Approximately 5% dissolved in two months; 50% dissolved in four months; most of the suture mass dissolved in six months.
Clinical Outcomes (Scars)	No clinically significant or statistical difference from control group using Hollander Cosmesis scale	No clinically significant or statistical difference in overall Hollander Cosmesis scores (unblinded & blinded) or individual components.
Clinical Outcomes (Pain)	Balanced at observation intervals, no clinically significant or statistical differences from control group.	Balanced at observation intervals, no clinically significant or statistical differences.
Clinical Outcomes (AEs)	Distribution balanced, no statistically significant difference from control group.	Distribution balanced, no statistically significant difference.
Wound Dehiscences	No full wound dehiscences (expected outcome for both groups)	No full wound dehiscences were noted.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size (Clinical): 171 patients (randomized into treatment and control groups). The distribution of numbers between treatment and control is not explicitly stated, but they are described as "balanced."
Data Provenance: Prospective clinical trial conducted at two sites. The country of origin is not explicitly stated in the provided text.
Sample Size (Pre-clinical/Animal): Not specified beyond "Animal Surgery Studies."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Clinical Study:
- Unblinded Assessments: "Forty investigators" enrolled patients and evaluated scars for abnormalities. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed, but they are implied to be medical professionals performing surgical procedures and follow-ups.
- Blinded Assessments: "an independent blinded plastic surgeon" evaluated pictures of patients' surgical wounds. The specific number is "an" (singular) independent plastic surgeon. Their years of experience are not specified.
Pre-clinical Studies: Expertise for biocompatibility, in vivo tensile strength, and barb holding strength would be from laboratory and animal study personnel, but specific numbers and qualifications are not mentioned.

4. Adjudication Method for the Test Set

Clinical Study:
- For unblinded assessments by the 40 investigators, no explicit adjudication method is described. It's implied that individual investigators made their assessments.
- For blinded assessments, a single "independent blinded plastic surgeon" made the evaluations, so there was no multi-reader adjudication process stated for this part of the assessment.
- Statistical analysis was used to compare the groups, which is a form of adjudicating overall group differences.

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

No, an MRMC study was not done.
This study is for a medical device (surgical suture), not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical surgical suture, not an algorithm or AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Clinical Study:
- Hollander Cosmesis Scale: Used for scar assessment, representing a standardized clinical rating scale. This likely relies on expert observation and clinical judgment.
- Pain Assessment: Patient-reported or clinician-assessed pain scores.
- Adverse Events: Clinically observed and reported events.
- Wound Dehiscence: Clinical observation of wound integrity.
Pre-clinical Studies:
- Biocompatibility: Based on standardized tests (ISO Biological Evaluation of Medical Device Standard 10993).
- Mechanical Properties (Tensile Strength, Barb Holding Strength): Measured using laboratory methods.
- Absorption Profile: Measured through various analytical techniques in vivo.
- Animal Surgery: Direct observation of surgical outcomes in animal models.

8. The Sample Size for the Training Set

Not applicable in the context of an AI device. For this medical device, there isn't a "training set" in the machine learning sense. The development of the suture's design and manufacturing processes would be informed by prior research and engineering principles, but not a data-driven training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there's no "training set" for this type of medical device. The "ground truth" for the device's design and initial performance targets would be established through material science research, preclinical testing, and comparison to existing predicate devices.

Summary

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K042075 page 1/3

OCT 2 6 2004

Section E - 510(k) Summary

Applicant Contact: 1.

Submission Contact:

Lois Smart QA Director Quill Medical, Inc. 2505 Meridian Drive, Suite 150 Research Triangle Park, NC 27713 Phone: 919-806-1961 Fax: 919-806-1953 Email: 1smart@quillmedical.com Date Prepared: 10-18-04

John F. Schaefer, Ph.D. Regulatory Consultant Lachman Consultant Services, Inc. 1600 Stewart Avenue Westbury, NY 11590 201-818-6777 201-818-4084 JFSNMC@aol.com

2.	Name of Device:	Quill™ Synthetic Absorbable Barbed Suture
	Common Name:	Polydioxanone Absorbable Surgical Sutures
	Classification Name:	Absorbable Polydioxanone Surgical Suture
		Regulation 21 CFR 878.4840, Product Code NEW

Identification of the legally marketed device to which the submitted claims 3. equivalence:

The Quill™ Synthetic Absorbable Barbed Suture is substantially equivalent to predicate device PDS II, a Synthetic Monofilament Absorbable Suture manufactured by Ethicon, Inc. PDS II was reclassified from Class III into Class II as documented in Docket 99P-5589.

Device Description: 4.

The Quill™ Synthetic Absorbable Barbed Sutures approximate tissues by using the opposing barbs on the suture surface imbedded in the tissues after the surgeon suture pierces the skin and appropriately places the suture within the tissues. The barbs on the Quill suture form an alternative method than knots in conventional suture for holding the two ends of a suture together.

Intended Use of the Device: 5.

Quill™ Synthetic Absorbable Barbed Sutures are indicated to close easily approximated edges of dermis where use of absorbable sutures is appropriate.

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Ko42075 page 2/3

Section E - 510(k) Summary (continued)

Parameter	New device	Predicate device
	QuillTM SyntheticAbsorbable Barbed Suture	Ethicon SyntheticMonofilament AbsorbablePDS II Suture
Chemical	Poly (p-dioxanone)	Poly (p-dioxanone)
USP Sizes	2-0 to 2	9-0 to 2
Oversized Diameter	Yes	Yes
Tensile StrengthEquivalence	Quill Size 2-0Quill Size 0Quill Size 2	USP Size 4-0USP Size 3-0USP Size 0
Approximates Tissueswith:	Barbs	Knots
	100 % - 0 months	100 % - 0 months
Absorption Profile% Remaining at Time	~ 101 % - 2 months	~ 100 % - 2 months
	~ 94 % - 4 months	~ 100 % - 4 months
	~ 18 % - 6 months	~ 26 % - 6 months
	100 % - 0 week	100 % - 0 week
Strength RetentionProfile% Strength at Time	~ 81 % - 2 week	~ 70 % - 2 week
	~ 79 % - 4 week	~ 50 % - 4 week
	~ 42 % - 6 week	~ 25 % - 6 week

Technological characteristics of the device in comparison to those of the 6. predicate device:

Pre-clinical and Clinical Summary 7.

Biocompatibility Summary

Quill Medical performed extensive biocompatibility studies with the Synthetic Monofilament Absorbable PDO Sutures using protocols consistent with appropriate sections of ISO Biological Evaluation of Medical Device Standard 10993. Data presented demonstrate that Quill PDO Sutures are non-toxic, non-hemolytic, nonirritating, non-pyrogenic, non-allergenic, non-sensitizing, non-cytotoxic, non-reactive and biocompatible.

In Vivo Tensile Strength

In vivo tensile strength studies demonstrate that Quill Medical PDO Sutures lose tensile strength during the critical wound healing period: approximately 20% of initial tensile strength is lost in two weeks; 20% is lost in four weeks; 60% is lost in six weeks.

Barb Holding Strength

In vivo barb holding strength of Quill PDO Sutures decreases slightly after implantation, remains relatively constant for approximately four weeks after implantation and retains sufficient tensile strength to approximate tissues during the critical wound period.

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K042075 page 3/3

Absorption Profile

Quill PDO Sutures are hydrolytically degraded in tissues with approximately 5% of the Quin I Do Batales are lyed in two months; 50% being dissolved in four months; and most of the suture mass being dissolved in six months. The degradation products are subsequently absorption by tissues and excreted from the body.

Animal Surgery Summary

Ammal Bargeryations and results from in vivo animal surgery studies Quill PDO Sutures East on ocustely used as the sole suture material to close dermal, subcutaneous and muscle incisions.

Clinical Summary

Forty investigators enrolled one hundred and seventy-one patients into a Quill Medical randomized clinical trial at two sites. The demographics for the treatment and control groups were balanced and confirm that randomization procedure was successful. Unblinded investigators evaluated scars for abnormalities at various intervals during and after hospitalization. No full wound dehiscences were noted.

Post-operative pain was assessed and found to be balanced at the observation intervals and presented no clinically significant or statistical differences between the two groups. Administration of post-operative pain medications during the observed recovery period was balanced between the treatment and the control groups.

Scars were clinically assessed using the Hollander Cosmesis scale at 5 weeks postoperatively. There is no clinically significant or statistical difference in the overall unblinded Hollander Cosmesis scores and the individual Hollander Cosmesis components of the treatment and control groups.

Pictures of patients' surgical wounds at the fifth post-operative week were evaluated by an independent blinded plastic surgeon. There is no clinically significant and no statistical difference in the overall blinded and individual component blinded Hollander Cosmesis scores of wound pictures from the treatment and control groups.

There were no clinically significant and no statistical differences between the unblinded and the blinded overall Hollander Cosmesis scores for surgical wounds between the treatment and the control groups.

Twenty-eight (28) patients reported thirty-two (32) adverse events (AEs) during the clinical trial. The AEs were typical of those expected following routine surgery. The distribution of AEs was balanced with no statistically significance difference between the treatment and control groups.

Substantial Equivalence Conclusion 8.

Based on the data and table above, the Quill™ Synthetic Absorbable Barbed Suture is substantially equivalent to predicate device PDS II manufactured by Ethicon, Inc.

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Image /page/3/Picture/1 description: The image is a circular seal with the logo of the U.S. Department of Health and Human Services. The seal features the department's emblem, which is a stylized representation of an eagle with three bars extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 6 2004

Quill Medical, Inc. c/o John F. Schaefer, Ph.D. Lachman Consultant Services, Inc. 1600 Stewart Avenue Westbury, New York 11590

Re: K042075

K042073
Trade/Device Name: Quill™ Synthetic Absorbable Barbed Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: II Product Code: NEW Dated: September 10, 2004 Received: September 13, 2004

Dear Dr. Schaefer:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector 310(t) pressure is substantially equivalent (for the indications felerenced above and have actoring ally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1770, the encordance with the provisions of the Federal Food, Drug, devices mail have been reclassinou in access asproval of a premarket approval application (PMA). and Cosmetic Act (Tel) that to not request to the general controls provisions of the Act. The You may, therefore, market the as rees, polyde requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is classified (see ass roy als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations aff may be subject to suell additional connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Poderal Regerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dri a localite of our device complies with other requirements of the Act that IDA has made a acternmantions administered by other Federal agencies. You must of any reactal statutes and regulations and admited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - John F. Schaefer, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k)
The same of the many of a first of a lot stick as ticker to a legal This letter will allow you to begin harketing your avrice of your device of your device to a legally premarket notification. The PDA inding of substantal equate 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
s and the may be and to the same of a the receive to the receively a If you desire specific advice for your aconce of (240) 276-0115. Also, please note the regulation entitled, contact the Office of Complance at (210) 276-678-678-778-778-778-78-19-2014-11-11-11-2018-11-11-11-2018-11-11-11-2018-01-1 " Misoralianing of Iciercher to premainterial international the Act from the Division of Small other geleral information on your responsible in toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at the labor one in html Malluracturers, International and Golless http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section D - Statement of Indications for Use

K042075 510k number if known:

Quill™ Synthetic Absorbable Barbed Suture Device Name:

Indications for Use:

Quill™ Synthetic Absorbable Barbed Sutures are indicated to close easily Quill™ Syndlette Absorbable Barous Barbable sutures 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 (
) (PLEASE DO NOT WRITE SELVERED) OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Misiam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K042075

Regulation Number and Section

§ 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.