(28 days)
Quill™ MONODERM™ Knotless Tissue-Closure Device is institution where the use of absorbable sutures is appropriate.
The QuillTM MonodermTM Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic absorbable tissue- closure device that is intended for use in the closure of soft tissue. It 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 uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter
The provided text describes a medical device, the Quill™ Monoderm™ Knotless Tissue-Closure Device, and its 510(k) submission for clearance. However, it does not contain information about a study that establishes acceptance criteria and proves the device meets those criteria in the context of AI/ML device performance.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. This process typically involves non-clinical laboratory performance testing to show that the new device (in this case, an additional suture diameter size) performs comparably to the predicate and meets relevant standards (like USP monograph for absorbable sutures).
Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance, acceptance criteria, sample sizes for test/training sets, ground truth, experts, adjudication methods, or MRMC studies. These details are not present in the provided text.
The closest relevant information is about the performance tests conducted to demonstrate substantial equivalence, which primarily involve non-clinical laboratory testing.
Here's what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implied): Conformance to the USP monograph for absorbable sutures (as applicable).
- Reported Device Performance: "The results of this testing demonstrates that the Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design is substantially equivalent to the predicate device."
- Additional Tests Performed: In vitro post-hydrolysis tensile testing and in vivo resorption testing.
The following questions cannot be answered from the provided text as they pertain to AI/ML device performance studies, which are not described:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- 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)
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
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K141778 Page 1 of 2
JUL 3 0 2014
510(k) Summary
| Date Prepared: | June 6, 2014 | |
|---|---|---|
| Company: | Surgical Specialties Corporation100 Dennis Dr.Reading, PA 19606 | |
| Contact: | Kirsten Stowell FrancoSr. Regulatory Affairs Manager | |
| Phone: | 610-404-3367 | |
| Fax: | 610-404-3924 | |
| Email: | kstowell@surgicalspecialties.com | |
| Device trade name: | QuillTM MonodermTM Knotless Tissue-Closure Device (PGA-PCL), Variable Loop Design | |
| 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: | K122898: | QuillTM MonodermTM Knotless Tissue-ClosureDevice, Variable Loop Design, Size -0- |
| K123409: | QuillTM MonodermTM Knotless Tissue-ClosureDevice, Variable Loop Design, Size 2-0 | |
| K123836: | QuillTM MonodermTM Knotless Tissue-ClosureDevice, Variable Loop Design, Size 1 & 3-0 | |
| Description of thedevice: | The QuillTM MonodermTM Knotless Tissue-Closure Device,Variable Loop Design is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue.It is comprised of a copolymer of glycolide and e-caprolactone,undyed, or dyed with D&C Violet No. 2. The device is designedwith small uni-directional barbs along the long axis of the suturemonofilament which contains a welded primary loop andsecondary loop design at the distal end. It is available in diameter |
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:
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Quill™ MONODERM™ device is indicated for use in soft tissue Indications for Use: approximation where the use of absorbable sutures is appropriate.
Substantial Equivalence:
Performance tests:
The proposed additional diameter sizes, Size 4-0, of the Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design 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, Variable Loop Design 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, Variable Loop Design 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 and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of a human figure embracing a bird, which is a symbol of care and protection.
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 30, 2014
Surgical Specialities Corporation Ms. Kirsten Stowell Franco Senior Regulatory Affairs Manager 100 Dennis Drive Reading, Pennsylvania 19606
Re: K141778
Trade/Device Name: Quill" MONODERM " Knotless Tissue-Closure Device (PGA-PCL), Variable Loop Design Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/1-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: June 6, 2014 Received: July 2, 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 (2 ) CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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Page 2 - Ms. Kirsten Stowell Franco
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HIUMAN 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)
1414177 Device Name
Quill™ MONODERM™ Knotless Tissue-Closture Device (PGA-PCL), Variable Loop Design
Indications for Use (Describe)
Quill™ MONODERM™ Knothers Tissue-Closure Device is institution where the use of absorbable sutures is appropriate.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpan C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
" " " " " " " " " " " " " " " " " " : : : : . 17: 12: 11:11:11: Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Quill™ Monoderm™ Device Special 510(k)
FORM FDA 3881 (1/14)
1"30 Pal toking Surress (101) 411 6710
Page 13 of 176
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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.