(533 days)
Demetech Absorbable Polydioxanone Surgical Suture is indicated for use in all types of soft . tissue approximation including pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery, but not for use in adult cardiovascular, microsurgery and neural tissue. These sutures are useful where absorbable suture with extended wound support (up to six weeks) is desirable.
Demetech's Polydioxanone is a synthetic monofilament absorbable surgical suture composed of polyester polymers poly (p-dioxanone) and is supplied un-dyed violet with D & C violet #2. Demetech's Polydioxanone surgical sutures meet the requirements established by the United States Pharmacopeia (U.S.P.) for synthetic absorbable surgical sutures.
This 510(k) summary describes a Polydioxanone Synthetic Absorbable Monofilament Suture by Demetech Corporation, seeking substantial equivalence to existing predicate devices.
The document does not report on a study that proves the device meets acceptance criteria in the traditional sense of a clinical trial or a performance study with a defined acceptance criterion and specific performance metrics (e.g., sensitivity, specificity, accuracy, etc.) for a diagnostic or AI device.
Instead, this submission focuses on demonstrating substantial equivalence to predicate devices (CP Medical Mono-Dox Synthetic Polydioxanone Absorbable Suture and Ethicon PDS II Synthetic Absorbable Monofilament Suture) by showing that the new device has the same technological characteristics and meets the same performance requirements as defined by the United States Pharmacopeia (U.S.P.) for absorbable surgical sutures.
Therefore, the requested information elements related to diagnostic performance studies, sample sizes for test and training sets, expert review, MRMC studies, standalone performance, and ground truth establishment are not applicable to this type of device submission.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from USP 31, compared to predicate devices) | Reported Device Performance (vs. Predicates) |
|---|---|
| Suture Material: synthetic monofilament absorbable surgical suture composed of polyester polymers poly (p-dioxanone) | Same |
| Suture material offered un-dyed and dyed with D&C Violet No. 2 | Same |
| Suture Material supplied un-coated | Same |
| Suture Material: sterile, flexible, monofilament thread, various lengths and diameters, with or without needles | Same |
| Absorption profile: retains ~85% original tensile strength at 120 days, ~25% at 180 days; absorption essentially complete at 220 days | Same to Similar |
| Intended Use: general soft tissue approximation, pediatric cardiovascular tissue (growth expected), ophthalmic surgery; not for adult cardiovascular, microsurgery, neural tissue; extended wound support (up to six weeks) desirable. | Same |
| Meets USP 31 performance requirements for "Absorbable Surgical Suture" monograph | Same |
| Meets USP 31 performance requirements for Diameter | Same |
| Meets USP 31 performance requirements for "Tensile Strength" <881> | Same |
| Meets USP 31 performance requirements for "Needle Attachment" <871> | Same |
| Meets USP 31 performance requirements for "Suture Length Requirement" (95% of stated label length) | Same |
| Packaged in same or equivalent manner with sterile single/double package, labeling conforms to 21 CFR and USP XXXI | Same |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission does not detail a "test set" in the context of a clinical performance study. The performance evaluation is based on meeting established material and performance standards (USP) which are generally tested in laboratory settings.
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)
- Not Applicable. Ground truth in the context of expert review for diagnostic accuracy is not relevant to this type of device (surgical suture). The ground truth here is the established, published standards of the United States Pharmacopeia.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are for reconciling discrepancies among expert reviewers in diagnostic studies, which is not relevant here.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a surgical suture, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for demonstrating equivalence is adherence to the United States Pharmacopeia (USP) 31 standards for synthetic absorbable surgical sutures, as well as comparison to the characteristics of the legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable. This submission does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable. This submission does not involve a "training set" in the context of machine learning.
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510(K) Summary
Polydioxanone Synthetic Absorbable Monofilament Suture
JAN - 8 2010
This summary is submitted in accordance with the Safe Medical Device Act (SMDA) of 1990 and Title 21 CFR § 807.92. This summary demonstrates the equivalence of Demetech Sutures to those of the legally marked devices listed.
| Applicant: | Demetech Corporation, |
|---|---|
| 8935 NW 27th Street, Miami FL. 33172 | |
| Contact Person: | A. J. Dimercuriotony@demetech.us |
| Date Revised: | September 27, 2009 |
| Device Names: | |
| Trade Name: | DemeTECH Polydioxanone Synthetic Monofilament(PDO) Absorbable Suture |
| Common Name: | DemeTECH Synthetic PDO Monofilament AbsorbableSuture |
| Classification Name: | Absorbable Polydioxanone Surgical Suture |
Predicate Devices:
Demetech Polydioxanone (PDO) Synthetic Absorbable Suture is substantially equivalent to these predicate devices:
- . CP Medical Mono-Dox Synthetic Polydioxanone Absorbable Suture 510K Number K013274, CP Medical Portland Oregon
- . Ethicon PDS II Synthetic Absorbable Monofilament Suture Polydioxanone Suture PMA Number N 18331, Ethicon Inc
Device Description:
Demetech's Polydioxanone is a synthetic monofilament absorbable surgical suture composed of polyester polymers poly (p-dioxanone) and is supplied un-dyed violet with D & C violet #2. Demetech's Polydioxanone surgical sutures meet the requirements established by the United States Pharmacopeia (U.S.P.) for synthetic absorbable surgical sutures.
8935 NW 27 Street, Miami, Florida, 33172- USA Tel (305) 597-5277 · Toll Free (888) 324-2447 · Fax: (305) 437-7607 Web: www.demetech.us · Email tony@demetech.us
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Image /page/1/Picture/1 description: The image shows the logo for DemeTECH. The logo consists of a circular icon on the left and the word "DemeTECH." on the right. The icon contains a triangular shape inside the circle. The text is in a bold, sans-serif font.
510(K) Summary Polydioxanone Synthetic Absorbable Monofilament Suture
- A. Intended Use:
Demetech Absorbable Polydioxanone Surgical Suture is indicated for use in general soft tissue approximation including pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery, but not for use in adult cardiovascular, microsurgery and neural tissue. These sutures are useful where absorbable suture with extended wound support (up to six weeks) is desirable.
Technological Comparison to Predicate Devices:
COMPARISON TABLE DEMETECH POLYDIOXANONE TO PREDICATE DEVICES
| Suture Material is a synthetic monofilament absorbablesurgical suture composed of polyester polymers poly (p-dioxanone) | Same | Same | Same |
|---|---|---|---|
| Suture material is offered un-dyed and dyed with the FDA listedcolorant, D&C Violet No. 2 (21 CFR 74.3602) | Same | Same | Same |
| Suture Material is supplied un-coated | Same | Same | Same |
| Suture Material is designed being a sterile, flexible, monofilamentthread offered in a variety of lengths and a range of diameters withor without various needles attached. | Same | Same | Same |
| Suture material absorption begins as a loss of tensile strengthwithout appreciable loss of mass. Implantation studies in animalsindicate that Polydioxanone retains approximately 85% of itsoriginal tensile strength at 120 days post implantation, withapproximately 25% remaining at 180 days. Absorptionpolydioxanone surgical suture is essentially complete at 220 days. | Same | Same | Same toSimilar |
| The Suture Material is "Intended for Use" in general soft tissueapproximation including pediatric cardiovascular tissue wheregrowth is expected to occur and ophthalmic surgery, but notfor use in adult cardiovascular, microsurgery and neuraltissue. These sutures are useful where absorbable suture withextended wound support (up to six weeks) is desirable. | Same | Same | Same |
| Suture Material meets or exceeds the performance requirements for"Absorbable Surgical Suture" as defined in the Official Monographof the United States Pharmacopeia 31. | Same | Same | Same |
8935 NW 27 Street, Miami, Florida, 33172- USA Tel (305) 597-5277 · Toll Free (888) 324-2447 · Fax: (305) 437-7607 Web: www.demetech.us · Email_tony@demetech.us
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Image /page/2/Picture/1 description: The image shows the logo for "DemeTECH". The logo consists of a circular icon on the left and the company name on the right. The icon features a triangle inside a circle, and the company name is written in a bold, italicized font.
510(K) Summary Polydioxanone Synthetic Absorbable Monofilament Suture
Technological Comparison to Predicate Devices (continued)
| COMPARISON TABLE TO PREDICATE DEVICES | |||
|---|---|---|---|
| Comparison Items | DemetechPolydioxanoneSuture | CP Medical Mono-Dox | EthiconPDS II |
| Suture Materials meet the performancerequirements for Diameter as defined in theUnited States Pharmacopeia 31 | Same | Same | Same |
| Suture Material meets or exceeds the performancerequirements defined in the United StatesPharmacopeia 31 for "Tensile Strength" < 881 > | Same | Same | Same |
| Suture Material meets or exceeds the performancerequirements defined in the United StatesPharmacopeia 31 and the current edition USP 31for "Needle Attachment" < 871 > | Same | Same | Same |
| Suture Material meets or exceeds the performancerequirements defined in the United StatesPharmacopeia 31 for "Suture LengthRequirement" (95% of stated label length) | Same | Same | Same |
| Suture Material is packaged in a same or equivalentmanner with sterile single or double packagehaving labeling conforming to 21 CFR and USPXXXI. | Same | Same | Same |
Demetech Polydioxanone Suture is composed of the same material, as are the predicated devices and having the same design being a sterile, flexible, monofilament threads meeting all the requirements of the United States Pharmacopeia. Demetech Polydioxanone Synthetic Monofilament Absorbable Suture is manufactured in the same manner as the predicate devices, being composed of polyester polymers poly (p-dioxanone) and produced in operations considered standard in the fiber industry to form the finished suture fiber. The manufacturer supplies to Demetech the same suture materials as it does to other suture manufacturers including some of those listed above.
The information and the results of the performance testing presented demonstrate the substantial equivalence of Demetech's Polydioxanone Synthetic Monofilament Absorbable Suture to that of the predicate devices. It further demonstrates Demetech suture is safe and effective for its intended purpose.
8935 NW 27 Street, Miami, Florida, 33172- USA Tel (305) 597-5277 · Toll Free (888) 324-2447 · Fax: (305) 437-7607 Web: www.demetech.us · Email tony@demetech.us
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JAN - 8 2010
DemeTECH Corporation % Mr. Anthony Dimercurio Vice President of Manufacturing 8935 NW 27" Street Miami, Florida 33172
Re: K082097
Trade/Device Name: DemeTECH Polydioxanone Synthetic Monofilament (PDO) Absorbable Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW Dated: December 21, 2009 Received: January 06, 2010
Dear Mr. Dimercurio:
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.
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 - Mr. Anthony Dimercurio
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
urs,
fur
lkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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হবে
ార్లు
Image /page/5/Picture/1 description: The image shows the logo for "DemeTECH." The logo consists of a circular graphic to the left of the company name. The graphic contains a triangular shape inside of the circle. The company name is written in a stylized font, with the "T" in "TECH" being larger than the other letters. There is a registered trademark symbol to the right of the company name.
Intended Use Statement
Indication for use
510K Number:
Device Name: Demetech Absorbable Polydioxanone Surgical Suture. As per 21CFR 878.4840
Indication for Use:
Demetech Absorbable Polydioxanone Surgical Suture is indicated for use in all types of soft . tissue approximation including pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery, but not for use in adult cardiovascular, microsurgery and neural tissue. These sutures are useful where absorbable suture with extended wound support (up to six weeks) is desirable.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ And/Or Over the-Counter Use_ (Part 21 CFR 801; Subpart D) (21 CFR 801; Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Keane
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K082097
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.