(28 days)
Not Found
No
The device description and performance studies focus on the physical properties and performance of a knotless suture, with no mention of AI or ML.
No
The device is described as a "Tissue-Closure Device" used for closing soft tissue, which is a surgical tool rather than a therapeutic device that treats a disease or condition.
No
Explanation: The device is described as a "Knotless Tissue-Closure Device" intended for "closure of soft tissue," which indicates it is a surgical tool for treatment, not diagnosis. There is no mention of it being used to identify or analyze medical conditions.
No
The device description clearly states it is a "sterile, synthetic absorbable tissue- closure device" comprised of a "copolymer of glycolide and e-caprolactone" with "uni-directional barbs" and a "welded primary loop and secondary loop design". This describes a physical, hardware-based medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Quill™ MONODERM™ Knotless Tissue-Closure Device is a surgical device used to close soft tissue within the body. It is a physical implantable material used for wound closure.
- Intended Use: The intended use clearly states it's for "tissue-closure" where absorbable sutures are appropriate. This is a surgical procedure, not a diagnostic test.
- Device Description: The description details the material and design of a suture-like device, not a diagnostic test kit or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
The device is a surgical tool used for wound closure, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Quill™ MONODERM™ Knotless Tissue-Closure Device is institution where the use of absorbable sutures is appropriate.
Product codes
GAM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
K141778 Page 1 of 2
JUL 3 0 2014
510(k) Summary
| Date Prepared: | June 6, 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: | 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 Acid | |
| Product code, GAM | ||
| 21 CFR 878.4493 | ||
| Class II | ||
| Legally marketed device | ||
| to which the device is | ||
| substantially equivalent: | K122898: | QuillTM MonodermTM Knotless Tissue-Closure |
| Device, Variable Loop Design, Size -0- | ||
| K123409: | QuillTM MonodermTM Knotless Tissue-Closure | |
| Device, Variable Loop Design, Size 2-0 | ||
| K123836: | QuillTM MonodermTM Knotless Tissue-Closure | |
| Device, Variable Loop Design, Size 1 & 3-0 | ||
| Description of the | ||
| device: | 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 |
.
:
1
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.
2
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
3
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
4
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
5
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