(59 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 EIN system consists of flexible intramedullary fixation devices that vary in diameters and lengths, which can be cut to size intraoperatively. The EIN has a curved tapered tip to facilitate insertion and manipulation. The EIN is manufactured from Titanium Alloy.
This document describes a 510(k) premarket notification for a medical device called the Synthes Elastic Intramedullary Nail (EIN) System (Line Extension). It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
Here's why and what's typically found in a K-submission for devices like this:
- 510(k) Submissions Focus on Substantial Equivalence: The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics, or if it has different technological characteristics, that these do not raise new questions of safety and effectiveness.
- Performance Data for Well-Established Device Types: For devices like intramedullary fixation rods, which are well-established, the FDA typically relies on recognized standards (e.g., ASTM standards for mechanical testing of implants), prior predicate devices with a history of safe and effective use, and sometimes bench testing to show the new device meets those standards or is comparable to the predicate. Clinical studies with detailed performance metrics and acceptance criteria for algorithm performance are common for novel software devices or AI/ML-driven diagnostics, but not typically for a line extension of a mechanical implant unless a new indication or a significant change in design warrants it.
Based on the provided text, I cannot provide the requested information because it is not present. The document focuses on:
- Device Name: Synthes Elastic Intramedullary Nail (EIN) System (Line Extension)
- Classification: Intramedullary fixation rod (21 CFR 888.3020)
- Predicate Devices: Synthes Elastic Intramedullary Nail (EIN) System, Depuy Ace Nancy Nail
- Device Description: Flexible intramedullary fixation devices of varying diameters and lengths, cut to size intraoperatively, curved tapered tip, manufactured from Titanium Alloy.
- Intended Use: Fixation of diaphyseal fractures (narrow canal or high flexibility needed), upper extremity fractures in all patients, lower extremity fractures in pediatric or small-stature patients, metaphyseal/epiphyseal fractures (e.g., radial neck), and small long bones (e.g., carpal, tarsal). Emphasizes avoiding disruption to the bone growth plate in pediatric applications.
- Substantial Equivalence: States that comparative information supports substantial equivalence to the predicate devices.
What would be expected in a typical K-submission for a mechanical implant to demonstrate substantial equivalence (even if not explicitly detailed here):
- Bench Testing: Mechanical testing (e.g., bending strength, torsional strength, fatigue testing) according to relevant ASTM or ISO standards to show the new device performs at least as well as the predicate and meets established safety margins.
- Biocompatibility: Testing to ensure the material (Titanium Alloy) is biocompatible.
- Sterilization Validation: Data to show the sterilization process is effective.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study data, sample sizes, experts, adjudication, MRMC, or standalone performance for an AI model because this product is a physical medical device (an intramedullary nail), not an AI/software device, and the provided document is a 510(k) summary, which doesn't typically delve into such granular study details for device line extensions.
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K 042135
:
3.0 510(k) Summary
Page __________ of ___________________________________________________________________________________________________________________________________________________________
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 |
|---|---|
| Device Name: | Synthes Elastic Intramedullary Nail (EIN) System (Line Extension) |
| Classification: | 21 CFR 888.3020: Intramedullary fixation rod |
| Predicate Devices: | Synthes Elastic Intramedullary Nail (EIN) SystemDepuy Ace Nancy Nail |
| Device Description: | The Synthes EIN system consists of flexible intramedullaryfixation devices that vary in diameters and lengths, which can becut to size intraoperatively. The EIN has a curved tapered tip tofacilitate insertion and manipulation. The EIN is manufacturedfrom Titanium Alloy. |
| 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: | Comparative information presented supports substantialequivalence. |
| The term "substantial equivalence" as used in this 510(k)notification is limited to the definition of substantial equivalencefound in the Federal Food, Drug and Cosmetic Act, as amendedand as applied under 21CFR 807, Subpart E under which a devicecan be marketed without premarket approval or reclassification. Adetermination of substantial equivalency under this notification isnot intended to have any bearing whatsoever on the resolution ofpatent infringement suits or any other patent matters. Nostatements related to, or in support of substantial equivalenceherein shall be construed as an admission against interest under theUS Patent Laws or their application by the courts. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved shapes resembling a bird in flight or flowing water.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 - 2004
Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, Pensylvania 19301
Re: K042135
Device Name: Synthes (USA) Elastic Intramedullary Nail (EIN) System (Line Extension) Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: August 6, 2004 Received: August 9, 2004
Dear Ms. Boyle:
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. Lisa M. Boyle
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N Millenson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0
Indications for Use
510(k) Number (if known):
Device Name:
Synthes (USA) Elastic Intramedullary Nail (EIN) System (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 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.
Mark N Milkenson
Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K042135
X 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.