(79 days)
The I.T.S. Claviculatplate with Angular Stability is a titanium implant fracture fixation system for repairing fractures located from the middle third to the distal third of the clavicle. Indications for Use include metaphysial and diaphysial fracture fixation of acute fractures, malunions, and non-unions of the clavicle. Other indications include corrective osteotomy and open and closed fractures. The system is not intended for spinal use.
The I.T.S. Claviculaplate with Angular Stability is a low-profile universal left and right titanium plate with various length cortical and/or cancellous self-tapping stabilization screws. The claviculaplate is made from CP titanium according to ASTM F 67-00 and the screws are made from 6-4 alloyed titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.
The provided document (K050862) is a 510(k) summary for a medical device called "Claviculaplate with Angular Stability." This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
Crucially, this document does not describe a study to prove the device meets acceptance criteria in the manner typically associated with clinical trials or performance evaluations of diagnostic or AI-driven systems.
Instead, the "acceptance criteria" for a device seeking 510(k) clearance are related to demonstrating substantial equivalence to an already approved predicate device. This typically involves showing that the new device has the same intended use, similar technological characteristics, and that any differences in technological characteristics do not raise new questions of safety or effectiveness.
Therefore, many of the requested points are not applicable to a 510(k) submission for a non-diagnostic, non-AI medical implant like a bone plate. I will address the relevant points and indicate when information is "not applicable."
1. A table of acceptance criteria and the reported device performance
For a 510(k) of a bone plate, the "acceptance criteria" are demonstrating substantial equivalence. The reported "performance" is that it is substantially equivalent to predicate devices.
| Acceptance Criteria (for 510(k) Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Same as predicate device | The device's intended use (stabilize clavicle fractures, not for spinal use) is consistent with predicate bone plates. |
| Technological Characteristics: Similar to predicate device, or differences do not raise new questions of safety/effectiveness | The device is a "low-profile universal left and right titanium plate with various length cortical and/or cancellous self-tapping stabilization screws." It is made from CP titanium (ASTM F 67-00) and screws from 6-4 alloyed titanium (ASTM F 136-02), surface conditioned with TIODIZE, Type II preparation. These characteristics are similar to predicate devices (Synthes and Acumed bone plate systems). |
| Material Composition: Biocompatible and known in medical use | Plate from CP titanium (ASTM F 67-00), Screws from 6-4 alloyed titanium (ASTM F 136-02). These materials are standard for orthopedic implants and are found in predicate devices. |
| Functional Equivalence: Performs the same basic function | The device is intended for "fracture fixation of the clavicle," which is the same function as predicate bone plate systems. |
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. A "test set" in the context of diagnostic or AI performance evaluation is not relevant to this 510(k) submission. Substantial equivalence for this type of device is typically demonstrated through engineering analyses (mechanical testing, material characterization) and comparison to predicate device specifications, rather than clinical trial data. The document does not mention any clinical or comparative study data of this nature.
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. No "test set" with "ground truth" established by external experts for performance evaluation is mentioned in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No external adjudication method is mentioned or required for this type of 510(k) submission.
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 device is a bone plate, not a diagnostic or AI-assisted system. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a bone plate, not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. "Ground truth" in the context of diagnostic or AI models is not relevant to this 510(k) submission for a bone plate. The "ground truth" for showing substantial equivalence relies on established standards for materials, manufacturing, and mechanical performance, and documented performance of legally marketed predicate devices.
8. The sample size for the training set
- Not applicable. This device is a bone plate and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this device.
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510(k) Summary of Safety and Effectiveness Section XII:
| SAFE MEDICAL DEVICES ACT OF 1990510(k) Summary | |
|---|---|
| NAME OF FIRM: | I.T.S. Implantat-Technologie-Systeme GmbH.Autal 28.Lassnitzhoehe A-8301AUSTRIA |
| 510(k) FIRM CONTACT: | Al LippincottEngineering Consulting Services, Inc.3150 E. 200th St.Prior Lake, MN 55372 |
| TRADE NAME: | Claviculaplate with Angular Stability |
| COMMON NAME: | Bone Plate System |
| CLASSIFICATION: | Plate, Fixation, Bone |
| (see 21 CRF, Sec. 888.3030). | |
| DEVICE PRODUCT CODE: HRS | |
| SUBSTANTIALLYEQUIVALENT DEVICES | Synthes Curved Reconstruction Plate (K011334)Synthes One -Third Tubular DCL Plate (K011335)Acumed Clavicle/Congruent Plate (K012655)Synthes Hook Plate |
| DEVICE DESCRIPTION: | The I.T.S. Claviculaplate with Angular Stability is a low-profileuniversal left and right titanium plate with various length corticaland/or cancellous self-tapping stabilization screws. Theclaviculaplate is made from CP titanium according to ASTM F 67-00 and the screws are made from 6-4 alloyed titanium according toASTM F 136-02. The plate and screws are surface conditionedwith a TIODIZE, Type II preparation. |
| INTENDED USE: | The I.T.S. Claviculaplate with Angular Stability is used to stabilizea fracture of the clavicle bone. The system is not intended forspinal use. |
| BASIS OF SUBSTANTIALEQIVLAENCE: | The I.T.S. Claviculaplate with Angular Stability is substantiallyequivalent to the Synthes and Acumed bone plate systems. |
| SUMMARY OF SAFETYAND EFFECTIVENESS: | The I.T.S. Claviculaplate with Angular Stability is shown to be safeand effective for use in fracture fixation of the clavicle. |
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Public Health Service
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles a human figure with three arms or lines extending from the head.
JUN 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
I.T.S. Implantat-Technologie-Systeme GmbH C/o Mr. Al Lippincott U.S. Agent and Official Correspondent Engineering Consulting Services Incorporated 3150 E. 200th Street Prior Lake, Minnesota 55372
Re: K050852
Trade/Device Name: Claviculaplate with Angular Stability Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: March 28, 2005 Received: April 4, 2005
Dear Mr. Lippincott:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your Bection on (t) } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } reletect above and nave acteming marketed predicate devices marketed in interstate commerce use stated in the enerosure/ to regary inter of the Medical Device Amendments, or to devices that provisions of the may 20, 1970, and many of the Federal Food, Drug, and Cosmetic liave been recassified in ace 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 controls provibitions or and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is olassilion (controls. Existing major regulations affecting your device can be Inay of subject to sublivations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advisou mate 127 r e issual 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 ally I cueral statutes and regarations as and limited to: registration and listing (21 CFR Part 807); an the Ave Drequirements) ; good manufacturing practice requirements as set forth in the quality laoemig (21 CFR Part 800); 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. Al Lippincott
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manxemily of substantial equivalence of your device to a legally premarket notification. The PDA Intention of succeantal organ mailer 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 If you desire specific auvice for your de needed on on of the regulation entitled.
contact the Office of Compliance at (240) 276-0120. "Also, please note them of contact the Office of Compliance at (240) 210 of 20.77.97). You may obtain other
"Misbranding by reference to premarket notification" (21CFR Part - Disco of Small "Misbranding by releiched to premailson is and it the Act from the Division of Small
general information on your responsibilities under the Act from the (800) 6 general information on your responsibilities and its toll-fire number (800) 638-2041 or 1 Manufacturers, International and Consumer Fibilianses agov/cdrh/industry/support/index.html.
Sincerely yours,
M
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Implant-Technology-Systems GmbH
Geschäftsführende Gesellschafterin: Dr. Eva Ruprechter
Tel ++43 (0)316 211 21 0 Fax ++43 (0)316 211 21 20 office@its-implant.com
Indications for Use
510(k) NUMBER: K050852
DEVICE NAME: Claviculaplate with angular stability INDICATIONS FOR USE:
The I.T.S. Claviculatplate with Angular Stability is a titanium implant fracture fixation system for repairing fractures located from the middle third to the distal third of the clavicle.
Indications for Use include metaphysial and diaphysial fracture fixation of acute fractures, malunions, and non-unions of the clavicle. Other indications include corrective osteotomy and open and closed fractures.
The system is not intended for spinal use.
Prescription Use
AND/OR
Over-The-Counter-Use
(Per 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Signature
ivision Sign-Off) Division of C. **1, Restorative and Neurological Devices
510(k) Number K050852
Concurrence of CDRH, Office of Device Evaluation (ODE)
FN 163966 b DVR 093
ARA LN 5062 ATI 4376
§ 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.