(106 days)
MonoMax absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
The Aesculap® MonoMax Absorbable Sutures are sterile, monofilament, absorbable surgical sutures constructed of poly-4-hydroxybutyrate. The MonoMax sutures will be offered in sizes 2, 1, 0, 2-0, 3-0, 4-0, and 5-0. The sutures will be available in a variety of cut lengths with or without needles attached. The sutures will be available undyed, and dyed with the FDA approved colorant D&C Violet No.2 in accordance with Title 21 CFR, 74.3602.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical testing: must meet USP 28 standards | All specifications were met apart from diameter. |
| Biocompatibility testing: must meet ISO 10993-1 standards | All specifications were met. |
| Resorption profile: demonstrated through animal testing | All specifications were met. |
| Diameter | Not met (implied by "apart from diameter"). The text doesn't specify the accepted diameter range or the actual performance. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size for the test set used in this specific submission (K100876).
However, it states: "Please reference K082178 for performance data, which were collected by Tepha, Inc. for the predicate device, that were used to support the substantial equivalence of the MonoMax suture device." This indicates that the performance criteria were met by relying on data from a predicate device (TephaFLEX® Absorbable Suture, K082178/K081099/K052225).
- Sample Size for Test Set: Not specified in this document.
- Data Provenance: The performance data was collected by Tepha, Inc. for the predicate device. The country of origin and retrospective/prospective nature of that data are not mentioned in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This document describes a medical device (suture) and its performance is evaluated against technical specifications (USP 28, ISO 10993-1, animal testing for resorption profile), not against a 'ground truth' established by medical experts in the way that, for example, an AI diagnostic tool would be. Therefore, this information is not applicable to this type of device and study.
4. Adjudication Method for the Test Set
As mentioned above, this study evaluates technical specifications of a physical device. There is no mention of an adjudication method as it would apply to expert review of a "test set" in the context of diagnostic or interpretive tasks. The "adjudication" is essentially the determination of whether the device meets the predefined technical standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study is focused on demonstrating the technical performance of a medical device (suture) against established standards, not on evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this refers to a physical medical device (suture), not an algorithm or AI. Therefore, the concept of "standalone performance" in the context of AI is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on established industry and regulatory standards:
- USP 28 (United States Pharmacopeia) for mechanical testing.
- ISO 10993-1 (International Organization for Standardization) for biocompatibility.
- Animal testing for the resorption profile.
The "ground truth" is whether the device's physical and biological properties meet these pre-defined, quantitative standards.
8. The Sample Size for the Training Set
This document describes a performance evaluation of a physical medical device (suture) against predefined specifications, not an AI model. Therefore, the concept of a "training set" does not apply.
9. How the Ground Truth for the Training Set Was Established
As stated above, the concept of a "training set" is not applicable here. The ground truth for this device's performance is the adherence to established technical standards.
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| B. 510(k) SUMMARY (as required by 21 CFR 807.92) | JUL 14 2010 |
|---|---|
| Aesculap® MonoMax Absorable SutureJuly 13, 2010 | |
| COMPANY: | Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714 |
| CONTACT: | Kathy A. Racosky610-984-9291 (phone)610-791-6882 (fax)kathy.racosky@aesculap.com |
| TRADE NAME: | Aesculap® MonoMax Poly(hydroxybutyrate) Absorbable Suture |
| COMMON NAME: | Poly(hydroxybutyrate) Absorbable Suture |
| CLASSIFICATION NAME: | Absorbable poly(hydroxybutyrate) surgical suture |
| REGULATION NUMBER: | 878.4494 |
| PRODUCT CODE: | NWJ |
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the MonoMax Absorbable Suture is substantially equivalent to the TephaFLEX® Absorbable Suture (K082178/K081099/K052225).
DEVICE DESCRIPTION
The Aesculap® MonoMax Absorbable Sutures are sterile, monofilament, absorbable surgical sutures constructed of poly-4-hydroxybutyrate. The MonoMax sutures will be offered in sizes 2, 1, 0, 2-0, 3-0, 4-0, and 5-0. The sutures will be available in a variety of cut lengths with or without needles attached. The sutures will be available undyed, and dyed with the FDA approved colorant D&C Violet No.2 in accordance with Title 21 CFR, 74.3602.
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K100876 pg. 2 of 2
Page 2 of 2
INDICATIONS FOR USE
MonoMax absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))
The MonoMax sutures are offered in the same range of sizes as the predicate devices. The material used for the MonoMax sutures is the same as that used to manufacture the predicate devices.
PERFORMANCE DATA
Testing was performed in accordance to FDA's Class II Special Control Guidance Document for Surgical Sutures, including mechanical testing in accordance to USP 28, biocompatibility testing in accordance to ISO 10993-1, and animal testing to demonstrate the resorption profile of the device. All specifications were met apart from diameter. Please reference K082178 for performance data, which were collected by Tepha, Inc. for the predicate device, that were used to support the substantial equivalence of the MonoMax suture 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 consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and is in a simple, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Aesculap® Inc. % Ms. Kathy A. Rocosky Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
JUL 1 4 2010
Re: K100876
Trade/Device Name: Aesculap® MonoMax Absorable Suture Regulation Number: 21 CFR 878.4494 Regulation Name: Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology. Regulatory Class: II
Product Code: NWJ Dated: June 15, 2010 Received: June 16, 2010
Dear Ms. Rocosky:
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
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Page 2 .- Ms. Kathy A. Rocosky
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 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/Resourcesfor You/Industry/default.htm.
Sincerel yours.
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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MonoMax Absorbable Suture
Page 1 of 1
1008740 Pg. 1 of
INDICATIONS FOR USE STATEMENT A.
510(k) Number:
Device Name: Aesculap® MonoMax Absorable Suture
×
Indications for Use:
MonoMax absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Prescription Use __
__ and/or Over-the-Counter Use
(per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED). Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Keane for Mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100876
§ 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
(a)
Identification. An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) technology. The device is intended for use in general soft tissue approximation and ligation.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology.” For the availability of this guidance document see § 878.1(e).