(12 days)
The Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.
The Synthes Elastic Intramedullary Nail (EIN) End Cap is used with the Synthes Elastic Intramedullary Nail (EIN) System. The end cap is inserted over the external portion of the nail and threaded into the cancellous bone in an oblique orientation.
The provided text describes a 510(k) summary for a medical device, the "Synthes (USA) Elastic Intramedullary Nail (EIN) End Cap, Line Extension". This type of submission to the FDA is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a study with performance metrics in the way a novel AI/software device would.
Therefore, the document does not contain the information typically required to fill out a table of acceptance criteria and reported device performance for an AI/software device, nor does it describe a study like those requested in questions 2 through 9.
Here's why and what information is available:
- Type of Device: This is an implantable medical device (intramedullary nail end cap), not an AI or software device. Substantial equivalence for such devices often relies on comparison of design, materials, manufacturing processes, and intended use to a predicate device, rather than performance metrics from a clinical study with ground truth.
- Regulatory Pathway: The 510(k) pathway (K082148) for this device is focused on showing substantial equivalence to existing predicate devices (Synthes Stainless Steel Elastic Intramedullary Nail (EIN) System - K081452 and Synthes Elastic Intramedullary Nail (EIN) End Cap - K053105).
- Lack of Performance Data: The 510(k) summary explicitly states "Information presented supports substantial equivalence" but provides no information about acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy, F-score), sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set details. These are all concepts relevant to the evaluation of AI/software as a medical device (SaMD) or AI-assisted devices, which this product is not.
In summary, based on the provided text, I cannot complete the requested tables and information because the document describes a traditional medical device undergoing a 510(k) substantial equivalence review, not an AI/software device with performance criteria and a study as typically outlined for such technologies.
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Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. There is a line underneath the word "SYNTHES" and the logo. There is a registered trademark symbol to the right of the word.
AUG 11 2008
:
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA)1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6538 | |
| Device Name: | Synthes (USA) Elastic Intramedullary Nail (EIN) End Cap, LineExtension | |
| Classification: | 21 CFR 888.3020: Intramedullary fixation rod (HSB) | |
| Predicate Devices: | Synthes Stainless Steel Elastic Intramedullary Nail (EIN) System(K081452)Synthes Elastic Intramedullary Nail (EIN) End Cap (K053105) | |
| Device Description: | The Synthes Elastic Intramedullary Nail (EIN) End Cap is usedwith the Synthes Elastic Intramedullary Nail (EIN) System. Theend cap is inserted over the external portion of the nail andthreaded into the cancellous bone in an oblique orientation. | |
| Intended Use: | The Synthes Elastic Intramedullary Nail (EIN) System is indicatedfor fixation of diaphyseal fractures where the canal is narrow orflexibility of the implant is paramount. This includes upperextremity fractures in all patients and lower extremity fractures inpediatric or small-stature patients. This system is also intended totreat metaphyseal and epiphyseal fractures, such as radial neckfractures and is intended for fixation of small long bones, such ascarpal and tarsal bones. In pediatric applications, the flexibility ofthe EIN allows it to be inserted at a point which avoids disruptionto the bone growth plate. | |
| SubstantialEquivalence: | Information presented supports substantial equivalence. |
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Image /page/1/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 image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 2008
Synthes (USA) % Ms. Jill R. Sherman Regulatory Affairs/Compliance Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Rc: K082148
Trade/Device Name: Synthes (USA) Elastic Intramedullary Nail (EIN) End Cap Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: July 29, 2008 Received: July 30, 2008
Dear Ms. Sherman:
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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Ms. Jill R. Sherman
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Mark W. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
KO82148
Device Name:
2.0
Synthes (USA) Elastic Intramedullary Nail (EIN) End Cap, Line Extension
Indications for Use:
The Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.
Prescription Use (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Mark Concurrence of DRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K08
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.