(106 days)
No
The summary describes a surgical suture and its material properties, intended use, and performance testing. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
No.
This device is an absorbable surgical suture, which is used for approximation and/or ligation of soft tissues. While it is used in a medical context, it does not directly treat or prevent a disease or condition; rather, it facilitates the healing process by holding tissues together.
No
Explanation: The device is an absorbable surgical suture, used for soft tissue approximation and ligation, which are therapeutic and restorative functions, not diagnostic ones.
No
The device described is a physical surgical suture, not a software application. The description details the material, sizes, and physical characteristics of the suture.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "general soft tissue approximation and/or ligation". This describes a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a surgical suture, which is a physical material used to close wounds or tie off blood vessels during surgery. This is a therapeutic/surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NWJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general 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)
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.
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
§ 878.4494 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).
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Page 1 of 2
| B. 510(k) SUMMARY (as required by 21 CFR 807.92) | JUL 14 2010 |
|---|---|
| Aesculap® MonoMax Absorable Suture | |
| July 13, 2010 | |
| COMPANY: | Aesculap®, Inc. |
| 3773 Corporate Parkway | |
| Center Valley, PA 18034 | |
| Establishment Registration Number: 2916714 | |
| CONTACT: | Kathy A. Racosky |
| 610-984-9291 (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.
2
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
3
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