(29 days)
MONODERM™ (PGA-PCL) suare is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Monoderm™ (PGA-PCL) suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and e-carpolactone. The Monoderm™ (PGA-PCL) suture is available dyed and undyed in Size 1 through Size 6-0.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Monoderm™ (PGA-PCL) Surgical Suture, structured according to your request:
Acceptance Criteria and Study for Monoderm™ (PGA-PCL) Surgical Suture
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device must conform to) | Reported Device Performance (How the device met the criteria) |
|---|---|
| USP monograph for absorbable sutures | Conforms to the USP monograph for absorbable sutures |
| Performance requirements for substantial equivalence to predicate device | Demonstrates substantial equivalence to the predicate device, including in vitro post-hydrolysis tensile testing |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for a "test set" in terms of individual sutures tested. The reference is to "performance testing" being conducted. The data provenance is implied to be from non-clinical laboratory testing conducted by the company, Surgical Specialties Corporation, likely in the USA (given the company's address and FDA submission). The nature of the testing suggests it is prospective in the sense that the new Monoderm™ (PGA-PCL) suture was manufactured and then subjected to these tests to evaluate its properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for suture performance is typically established by physical and chemical properties measured against established standards (like the USP monograph), rather than expert human interpretation of images or other subjective data. Therefore, expert consensus in the traditional sense is not directly applicable here.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used for human review of subjective data, typically in diagnostic imaging or clinical trials where expert consensus is needed. For product performance testing of a physical device like a suture, the assessment is based on measured physical properties against predefined specifications, not human adjudication of subjective findings.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This submission is for a physical surgical suture, not an AI device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone study (in the context of an algorithm) was not done. This submission is for a physical surgical suture.
7. The Type of Ground Truth Used
The ground truth used for evaluating the suture's performance is based on:
- Established standards and specifications: Specifically, the USP monograph for absorbable sutures.
- Comparative data against a legally marketed predicate device: "in vitro post-hydrolysis tensile testing" to demonstrate substantial equivalence. This implies that the predicate device's performance characteristics served as a reference "ground truth" for comparison.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. This submission is for a physical medical device (suture) and does not involve an algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable as there is no training set for an algorithm in this context.
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510(k) Summary
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| Date Prepared: | February 26, 2014 |
|---|---|
| Company: | Surgical Specialties Corporation |
| 100 Dennis Dr. | |
| Reading, PA 19606 | |
| Contact: | Kirsten Stowell |
| Regulatory Affairs Manager | |
| Phone: 610-404-3367 | |
| Fax: 610-404-3924 | |
| Email: kstowell@angio.com | |
| Device trade name: | Monoderm™ (PGA-PCL) Surgical Suture |
| 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: | K052437: Monoderm™ (PGA-PCL) Surgical Suture |
| Description of thedevice: | Monoderm™ (PGA-PCL) suture is a monofilament syntheticabsorbable surgical suture prepared from a copolymer ofglycolide and e-carpolactone. The Monoderm™ (PGA-PCL)suture is available dyed and undyed in Size 1 through Size 6-0. |
| Indications for Use: | Monoderm™ (PGA-PCL) suture is indicated for use in generalsoft tissue approximation and/or ligation, but not for use incardiovascular or neurological tissues, microsurgery orophthalmic surgery. |
| SubstantialEquivalence: | The proposed additional diameter sizes, USP Size 1 and 0, of theMonoderm™ (PGA-PCL) suture product line have the samematerial, design, intended use and technological characteristics asthe predicate device. The only difference between the proposedand predicate device is the suture diameter. |
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K140227 Page 2/2
Non-clinical laboratory performance testing was conducted to Performance tests: confirm that the Monoderm™ (PGA-PCL) suture 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.
ﻟﻤ
The results of this testing demonstrates that the Monoderm™ (PGA-PCL) suture is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird in flight. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2014
Surgical Specialties Corporation Ms. Kirsten Stowell Regulatory Affairs Manager 100 Dennis Drive Reading, Pennsylvania 19606
Re: K140227
Trade/Device Name: MONODERM™ (PGA-PCL) Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/l-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: January 28, 2014 Received: January 30, 2014
Dear Ms. Stowell:
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 - Ms. Kirsten Stowell
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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)
Device Name
MONODERM™ (PGA-PCL) Surgical Suture
Indications for Use (Describe)
MONODERM™ (PGA-PCL) suare is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Type of Use (Select one or both, as applicable)
X 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) (Signature)
David Krause -S
FORM நூற்றி திரிப்பு (140) Jure 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.