(101 days)
Not Found
No
The summary describes a physical orthopedic fixation pin made of a resorbable material and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is used for fixation of bone fragments and tissue repair, which are therapeutic interventions.
No
The device is described as an orthopedic fixation pin for repairing bone and tissue fragments, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical orthopedic fixation pin made from a copolymer material, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
- Device Description and Intended Use: The Aesculap Resorbable Pin is a physical implant used for fixing bone fragments and other tissues within the body. It is a surgical device, not a diagnostic test performed on samples outside the body.
The information provided clearly describes a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Aesculap Resorbable Pin is intended for use in the fixation of fragments of non-load bearing bones, osteotomies, arthrodeses, meniscal tissue repair, and osteochondral repair.
Product codes
MAI
Device Description
The Aesculap Resorbable Pin is a small orthopedic fixation pin made from a copolymer material (Poly-L,DL -Lactide Co70/30) that is absorbed into the body over time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-load bearing bones, meniscal tissue, osteochondral
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
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
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C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
[in Accordance with SMDA of 1990]
Aesculap Resorbable Pin
25 April 2007
APR 3 € 2007
COMPANY: Aesculap® Implant Systems, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 3005673311
CONTACT: Matthew M. Hull, Regulatory Affairs Manager 800 258-1946 x 5072 (phone) 610 791-6882 (fax)
- Aesculap® Resorbable Pin TRADE NAME:
- COMMON NAME: Resorbable Orthopedic Pin
DEVICE CLASS: Class II
PRODUCT CODE: MAI
CLASSIFICATION: 21 CFR Section 888.3030: Fastener, Fixation, Biodegradable, Soft Tissue
REVIEW PANEL: Orthopedics
INDICATIONS FOR USE
The Aesculap Resorbable Pin is intended for use in the fixation of fragments of non-load bearing bones, osteotomies, arthrodeses, meniscal tissue repair, and osteochondral repair.
DEVICE DESCRIPTION
The Aesculap Resorbable Pin is a small orthopedic fixation pin made from a copolymer material (Poly-L,DL -Lactide Co70/30) that is absorbed into the body over time.
PURPOSE FOR SUBMISSION
The purpose for this submission is to gain marketing clearance for the Aesculap Resorbable Pin.
PERFORMANCE DATA
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device.
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems, Inc. believes that the Aesculap® Resorbable Pin is equivalent in materials and similar in use to the previously cleared Arthrex Meniscal Dart System (K983577) and the Bionx Smart Nail from ConMed Linvatec (K993074).
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 symbol with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2007
Aesculap® Implant Systems, Inc. % Mr. Matthew M. Hull Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K070178 Trade/Device Name: Aesulap® Resorbable Pin Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: January 19, 2007 Received: February 7, 2007
Dear Mr. Hull:
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 such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the ed economic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Matthew M. Hull
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Barbara Buchner
Mark N. Metkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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B. INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name: Aesculap Resorbable Pin
Indication for Use:
(Per 21 CFR 801.109)
The Aesculap Resorbable Pin is intended for use in the fixation of fragments of non-load bearing bones, osteotomies, arthrodeses, meniscal tissue repair, and osteochondral repair.
| Prescription Use | X |
|---|---|
| or Over-the-Counter Use |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milhone
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number
(Optional Format 3-10-98)