QUILL SYNTHETIC ABSORBABLE BARBED SUTURE

K042075 · Quill Medical, Inc. · NEW · Oct 26, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042075
• Device Name: QUILL SYNTHETIC ABSORBABLE BARBED SUTURE
• Applicant: Quill Medical, Inc.
• Product Code: NEW · General, Plastic Surgery
• Decision Date: Oct 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4840
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Quill™ Synthetic Absorbable Barbed Suture is a poly(p-dioxanone) monofilament suture featuring surface barbs; barbs eliminate need for traditional surgical knots by anchoring into tissue. Used by surgeons to approximate dermal tissue edges; device degrades hydrolytically over time. Clinical benefit includes secure wound closure without knot-related complications. Device is sterile, available in various lengths and needle configurations.

Clinical Evidence

Randomized clinical trial with 171 patients across 40 investigators. Primary endpoints included wound dehiscence, post-operative pain, and cosmesis (Hollander Cosmesis scale). Results showed no statistically significant differences in pain, adverse events, or cosmesis scores between Quill and control (PDS II) groups at 5 weeks post-op. No full wound dehiscences reported.

Technological Characteristics

Material: Poly(p-dioxanone). Form: Monofilament with surface barbs. Energy: None. Connectivity: None. Sterilization: Not specified. Biocompatibility: Compliant with ISO 10993. Degradation: Hydrolytic, ~50% mass loss at 4 months, near-complete at 6 months.

Indications for Use

Indicated for closing easily approximated dermal edges in patients where absorbable sutures are appropriate. No specific age or gender restrictions noted.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• PDS II (Synthetic Monofilament Absorbable Suture) (Ethicon, Inc.)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] Email: [e-mail] 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 [e-mail]

| 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 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.

#### 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 Synthetic<br>Absorbable Barbed Suture | Ethicon Synthetic<br>Monofilament Absorbable<br>PDS II Suture |
| Chemical | Poly (p-dioxanone) | Poly (p-dioxanone) |
| USP Sizes | 2-0 to 2 | 9-0 to 2 |
| Oversized Diameter | Yes | Yes |
| Tensile Strength<br>Equivalence | Quill Size 2-0<br>Quill Size 0<br>Quill Size 2 | USP Size 4-0<br>USP Size 3-0<br>USP Size 0 |
| Approximates Tissues<br>with: | Barbs | Knots |
| | 100 % - 0 months | 100 % - 0 months |
| Absorption Profile<br>% 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 Retention<br>Profile<br>% 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 [phone]. 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 [phone] 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