(29 days)
No
The device description and performance studies focus on the physical properties and performance of a surgical suture, with no mention of AI or ML capabilities.
No
The device, a surgical suture, is used for soft tissue approximation. Its function is to hold tissues together, which is a supportive role rather than directly curing or treating a disease/condition.
No
The device is described as a "knotless tissue-closure device" and an "absorbable suture" used for "soft tissue approximation." Its purpose is to physically approximate tissues, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a physical, sterile, synthetic absorbable tissue approximation device comprised of a copolymer and designed with barbs. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue approximation where the use of absorbable sutures is appropriate." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "sterile, synthetic absorbable tissue approximation device" (a suture). It is designed to be implanted in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health status. IVDs are used for diagnosis, monitoring, or screening based on analysis of these specimens.
Therefore, the Quill™ MONODERM™ device is a surgical suture, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Quilltrade mark MONODERMtrade mark device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.
Quilltrade mark MONODERMtrade mark Knoiless Tissue-Closure Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.
Product codes (comma separated list FDA assigned to the subject device)
GAM
Device Description
The Quilltrade mark Monodermtrade mark 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical laboratory performance testing was conducted to confirm that the Quilltrade mark Monodermtrade mark 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 Quilltrade mark Monodermtrade mark Knotless Tissue-Closure Device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 Corporation | |
| 100 Dennis Dr. | ||
| Reading, PA 19606 | ||
| Contact: | Kirsten Stowell Franco | |
| Sr. Regulatory Affairs Manager | ||
| Phone: 610-404-3367 | ||
| Fax: 610-404-3924 | ||
| Email: 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 Acid | |
| Product code, GAM | ||
| 21 CFR 878.4493 | ||
| Class II | ||
| Legally marketed device | ||
| to which the device is | ||
| substantially equivalent: | K072028: | Quill™ Monoderm™ (PGA-PCL) |
| K052437: | Monoderm™ (PGA-PCL) Surgical Suture | |
| Description of the | ||
| device: | 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. | ||
| Indications for Use: | Quill™ MONODERM™ device is indicated for use in soft tissue | |
| approximation 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.
2
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
3
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.
4
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)
5
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