(29 days)
Quill™ MONODERM™ device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.
The Quill™ Monoderm™ Knotless Tissue-Closure Device is a sterile, synthetic absorbable tissue approximation device that is comprised of a copolymer of glycolide and e-caprolactone, undyed, or dyed with D&C Violet No. 2. The device is designed with small bi-directional barbs along the long axis of the suture monofilament. It is available in diameter Sizes 0 to 5-0, in various lengths affixed to various needle types.
The provided text describes a 510(k) premarket notification for a medical device, the Quill™ Monoderm™ Knotless Tissue-Closure Device (PGA-PCL). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its performance against specific acceptance criteria in the manner typical for AI/ML-based devices.
Therefore, many of the requested categories for AI/ML device studies (such as MRMC studies, standalone performance, training set details, or expert ground truth establishment) are not applicable to the information contained in this submission.
Here's an analysis of the provided text in relation to your questions, focusing on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (What was measured) | Reported Device Performance (How the device measured up) |
|---|---|
| Conformance to USP monograph for absorbable sutures | Conforms to the USP monograph for absorbable sutures (as applicable). |
| In vitro post-hydrolysis tensile testing | Results demonstrate substantial equivalence to the predicate device. |
| In vivo resorption testing | Results demonstrate substantial equivalence to the predicate device. |
| Same material, design, intended use, and technological characteristics as predicate device (for new sizes) | The proposed additional diameter sizes (4-0 and 5-0) have these characteristics. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the performance tests (USP monograph, in vitro tensile, in vivo resorption). It also does not provide details about the provenance of the data, such as country of origin or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not relevant or provided for this device type (a surgical suture). Ground truth, in the context of this device, would be defined by standardized chemical and physical tests rather than expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable to the type of device and testing described. Performance was assessed via laboratory and in-vivo testing, not through adjudication of expert opinions.
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
Not applicable. This is a surgical suture, not an AI/ML-based diagnostic device where MRMC studies would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be established through:
- Physical and chemical standards: As defined by the USP monograph for absorbable sutures.
- Direct measurement: Of properties like tensile strength and resorption rates in vitro and in vivo.
The "ground truth" is objective measurement against established standards and comparisons to the predicate device, not expert consensus or pathology in the typical sense.
8. The sample size for the training set
Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no training set as this is not an AI/ML device.
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K141558 Page 1/2
510(k) Summary
.
JUL 1 1 2014
| Date Prepared: | July 1, 2014 | JUL 1 1 2014 |
|---|---|---|
| Company: | Surgical Specialties Corporation100 Dennis Dr.Reading, PA 19606 | |
| Contact: | Kirsten Stowell FrancoSr. Regulatory Affairs ManagerPhone: 610-404-3367Fax: 610-404-3924Email: kstowell@surgicalspecialties.com | |
| Device trade name: | Quill™ Monoderm™ Knotless Tissue-Closure Device (PGA-PCL) | |
| Device Common Name: | Absorbable Poly(glycolide/l-lactide) Surgical Suture | |
| Device classification: | Suture, Absorbable, Synthetic, Polyglycolic AcidProduct code, GAM21 CFR 878.4493Class II | |
| Legally marketed deviceto which the device issubstantially equivalent: | K072028: | Quill™ Monoderm™ (PGA-PCL) |
| K052437: | Monoderm™ (PGA-PCL) Surgical Suture | |
| Description of thedevice: | The Quill™ Monoderm™ Knotless Tissue-Closure Device is asterile, synthetic absorbable tissue approximation device that iscomprised of a copolymer of glycolide and e-caprolactone,undyed, or dyed with D&C Violet No. 2. The device is designedwith small bi-directional barbs along the long axis of the suturemonofilament. It is available in diameter Sizes 0 to 5-0, in variouslengths affixed to various needle types. | |
| Indications for Use: | Quill™ MONODERM™ device is indicated for use in soft tissueapproximation where the use of absorbable sutures is appropriate. |
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K141558 Page 2/2
Substantial Equivalence:
Performance tests:
The proposed additional diameter sizes, Size 4-0 and 5-0, of the Quill™ Monoderm™ Knotless Tissue-Closure Device product line have the same material, design, intended use and technological characteristics as the predicate device. The only difference between the proposed and predicate device is the suture diameter.
Non-clinical laboratory performance testing was conducted to confirm that the Quill™ Monoderm™ Knotless Tissue-Closure Device conforms to the USP monograph for absorbable sutures (as applicable). This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003. Additional performance testing was conducted in order to demonstrate substantial equivalence to the predicate device including in vitro post-hydrolysis tensile testing and in vivo resorption testing.
The results of this testing demonstrates that the Quill™ Monoderm™ Knotless Tissue-Closure Device is substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2014
Surgical Specialties Corporation % Angiotech Puerto. Inc. Kirsten Stowell Franco Sr. Regulatory Affairs Manager 100 Dennis Drive Reading, Pennsylvania 19606
Re: K141558
Trade/Device Name: Quill" Monoderm™ Knotless Tissue-Closure Device Regulation Number: 21 CFR 878.4493 Regulatory Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: June 10, 2014 Received: June 12, 2014
Dear Ms. Franco:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
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Page 2 - Kirsten Stowell Franco
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
David Krause -S
- for
Binita Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
cc: DMC 510(k) Staff Division D.O.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug AdminIstration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
441558 Device Name Quill™ MONODERM™ Knotless Tissue-Closture Device (PGA-PCL)
Indications for Use (Describe) Quill™ MONODERM™ Knoiless Tissue-Closure Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.
Type of Use (Select one or both, as applicable)
[ሬ] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Peter L. Hudson -S
FORM FDA 3881 (1/14) QuillTM Monoderm™ "* Device Special 510(k)
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§ 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.