(324 days)
Indications for the Sanatmetal Intramedullary Nails and Pins include traumatologic implants for the intramedullary fixation of fractures of tubular bones (femur, tibia, humerus), nonunions and malunions, i.e. diaphysis fractures, sub-trochanter fractures and femoral sub-trochanter fractures combined with diaphysis fractures, extra- and intraarticular fractures.
Sanatmetal Intramedullary Nails and Pins are single use devices.
The device is a stainless steel or titanium alloy nail for orthopaedic implantation. Depending on the model selected, the device may have none, any or all of the following features: cannulation, endcaps, slots, holes, anodized finish (titanium models only), locking screws.
The provided text describes a 510(k) premarket notification for "Sanatmetal Intramedullary Nails and Pins". This document is a regulatory submission for a medical device (intramedullary nails and pins for fracture fixation) and does not contain acceptance criteria or a study that proves the device meets specific performance criteria in the way a diagnostic or AI device submission would.
Instead, this submission establishes substantial equivalence to existing legally marketed predicate devices based on design features, operational principles, material composition, and non-clinical mechanical testing standards. Clinical testing was explicitly stated as "Not applicable to this device."
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, or MRMC studies, as these types of studies are not presented or required for this class of device submission based on the provided document.
The document's focus is on demonstrating that the new device is as safe and effective as pre-existing devices already on the market, primarily through engineering analysis and mechanical testing, not through clinical performance metrics against a defined standard.
To directly address the prompts based on the document's content, while acknowledging the limitations:
Description of Acceptance Criteria and Study to Prove Device Meets Criteria (Based on Provided Document)
The provided submission for the "Sanatmetal Intramedullary Nails and Pins" is a 510(k) premarket notification. For this type of submission, especially for a Class II orthopedic implant like an intramedullary nail, the primary "acceptance criterion" is Substantial Equivalence to legally marketed predicate devices. The "study" proving this is a combination of engineering analysis, material characterization, and non-clinical mechanical testing, rather than clinical performance studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance / Evidence Provided |
|---|---|
| Material Composition Equivalence: Similarity to predicate devices in materials used. | The device is a stainless steel or titanium alloy nail. The submission states that the subject device is "substantially equivalent, if not identical, to its predicate devices in terms of... materials of composition." This implies the materials (stainless steel or titanium alloy) are standard and comparable to those in the predicate devices. |
| Design Features Equivalence: Similarity to predicate devices in design, features, and dimensions. | The device description outlines features such as cannulation, endcaps, slots, holes, and anodized finish. The submission states "design features" are similar to predicate devices, and "design" is substantially equivalent. Engineering drawings are mentioned as evidence. |
| Operational Principles Equivalence: Functioning in a similar manner to predicate devices. | The device's intended use is intramedullary fixation of fractures. The submission asserts "operational principles" are similar to predicate devices. |
| Indications for Use Equivalence: Same indications as predicate devices. | The Indications for Use for the Sanatmetal device are listed: traumatologic implants for intramedullary fixation of fractures of tubular bones (femur, tibia, humerus), nonunions, malunions, diaphysis fractures, sub-trochanter fractures, combined diaphysis/sub-trochanter fractures, and extra- and intraarticular fractures. These are presented as being equivalent to the predicate devices. |
| Mechanical Performance (Non-Clinical): Meets recognized performance standards for orthopedic implants. | ASTM F1264-03 (Standard Specification and Test Methods for Intramedullary Fixation Devices) is cited as an FDA Recognized Performance Standard that the device's mechanical testing demonstrated compliance with. The submission states "mechanical testing have demonstrated that the subject device is substantially equivalent." |
| Safety and Effectiveness: No new questions of safety or effectiveness are raised compared to predicate devices. | The conclusion states: "Based on the 510(k) Summary and the information provided herein, we conclude that the Sanatmetal Intramedullary Nails and Pins are substantially equivalent to the existing legally marketed devices..." This implies that no new safety or effectiveness concerns were identified during the review of the non-clinical data. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission relies on non-clinical mechanical testing and comparison to existing predicate devices. Clinical test sets with human subjects are explicitly stated as "Not applicable to this device." The mechanical testing would involve a sample size of devices tested to ASTM F1264-03, but the exact number or provenance of these test articles is not detailed in the summary provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. There is no "ground truth" derived from expert consensus for clinical performance in this submission, as no clinical testing was performed or required. The "ground truth" for mechanical testing would be the specifications and requirements of the ASTM standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set requiring adjudication by experts is present in this documentation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is an orthopedic implant, not an AI or diagnostic imaging device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is an orthopedic implant; there is no algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical testing, the "ground truth" is compliance with the requirements and specifications of the FDA Recognized Performance Standard ASTM F1264-03.
- For the overall submission, the "ground truth" for substantial equivalence is the established safety and effectiveness profile of the legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of an AI or diagnostic device for this orthopedic implant submission.
9. How the ground truth for the training set was established
- Not Applicable. No training set exists for this device.
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SANATMETAL
Manufacturer of Orthopaedic and Traumatologic Products H-3301, Eger Faiskola út 5. Phone: +(36)36-512-900 Fax: +(36)36www.sanatmetal.hu == e-mail: metal@sanatmetal.hu 512-932
510(k) Statement of Summary
| A | 510(k) Owner | Sanatmetal Manufacturer of Orthopaedic And TraumatologicProducts3300 EgerFaiskola u. 5Hungary |
|---|---|---|
| Contact | Donald W. GuthnerOrgenix, LLC111 Hill RoadDouglassville, PA 19518(888) ORGENIX (674-3649)(484) 363-5879 (FAX)dg@orgenix.comFEB - 7 2008 | |
| Preparation Date | December 23, 2007 | |
| B | Trade Name | Intramedullary Nails and Pins |
| Common Name | Intramedullary Nails, Nails | |
| Classification | Intramedullary Fixation Rod21 CFR 888.3020Product Code: HSB | |
| C | Predicate Device(s) | Substantial equivalence for SanatMetal Intramedullary Nailsand Pins is based on its similarities in indications for usedesign features, operational principles and materialcomposition when compared to the predicate devices clearedunder the following submissions:• K051557, TriGen® Retrograde Femoral, Supracondylarand Tibial Nails;• K032722, TriGen® Straight Humeral Nail System;• K040212, TriGen® InterTAN;• K023115, Ace® VersaNail; and |
| D | Device Description | The device is a stainless steel or titanium alloy nail fororthopaedic implantation.Depending on the model selected, the device may have none,any or all of the following features: cannulation, endcaps, slots,holes, anodized finish (titanium models only), locking screws. |
| E | Intended Use | Indications for the Sanatmetal Intramedullary Nails and Pinsinclude traumatologic implants for the intramedullary fixationof fractures of tubular bones (femur, tibia, humerus), nonunionsand malunions, i.e. diaphysis fractures, sub-trochanter fracturesand femoral sub-trochanter fractures combined with diaphysisfractures, extra- and intraarticular fractures.Sanatmetal Intramedullary Nails and Pins are single usedevices. |
| F | TechnologicalCharacteristics | As was established in this submission, the subject device issubstantially equivalent to other devices cleared by the agencyfor commercial distribution in the United States.Engineering drawings, labeling, and mechanical testing havedemonstrated that the subject device is substantially equivalent,if not identical, to its predicate devices in terms of design,materials of composition, indications for use, and such othercharacteristics as may be associated with the manufacture ofany medical device. |
| G | Non-Clinical Testing | FDA Recognized Performance Standards• ASTM F1264-03 |
| H | Clinical Testing | Not applicable to this device |
| I | Conclusions | Based on the 510(k) Summary and the information providedherein, we conclude that the Sanatmetal Intramedullary Nailsand Pins are substantially equivalent to the existing legallymarketed devices under the Federal Food, Drug and CosmeticAct. |
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- J Additional Information NA
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wing-like shapes.
Public Health Service
FEB - 7 2008
od and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Orgenix, LLC % Mr. Donald Guthner 111 Hill Road Douglassville, PA 19518
K070761 Re: Re: Re:
Trade/Device Name: Sanatmetal Intramedullary Nails and Pins Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: February 4, 2008 Received: February 5, 2008
Dear Mr. Guthner:
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 - Mr. Donald Guthner
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 N Mulkerson
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): K070761
Device Name: Sanatmetal Intramedullary Nails and Pins
Indications for Use:
Indications for the Sanatmetal Intramedullary Nails and Pins include traumatologic implants for the intramedullary fixation of fractures of tubular bones (femur, tibia, humerus), nonunions and malunions, i.e. diaphysis fractures, sub-trochanter fractures and femoral sub-trochanter fractures combined with diaphysis fractures, extra- and intraarticular fractures.
Sanatmetal Nails and Pins are single use devices.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Barell
(Division Sign-Division of General, Restorative, and Neurological Devices
510(k) Number K070761
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§ 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.