(77 days)
Merete Compression Screws are indicated for fracture fixation and reconstruction of various bones, including
- osteotomies in the foot (as Hallux Valgus treatment) or hand, -
- arthrodesis in hand, foot or ankle surgery, 1
- fixation of bone fragments in long bones or small bone fractures. -
The size of the chosen screw should be adapted to the specific indication.
Merete Compression Screws are cannulated, self-drilling/self-tapping, dual pitched screws with a threaded head which can be countersunk into the bone. The screws are provided in the diameters 3.0 mm, 4.3 mm and 6.5 mm in various lengths and are available in Titanium alloy (Ti-6Al-4V).
This document does not contain information about a medical device with AI/ML capabilities, but rather a traditional medical device (compression screws), thus the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is not applicable in the context of an AI/ML device.
The provided text is a 510(k) summary for Merete Compression Screws, which are mechanical devices used for bone fixation. The document focuses on demonstrating substantial equivalence to predicate devices based on material, design, and intended use, rather than performance related to an AI/ML algorithm.
Therefore, I cannot extract the requested information as it pertains to an AI/ML device for the following reasons:
- Nature of the Device: The Merete Compression Screws are physical implants, not an AI/ML diagnostic or predictive tool.
- Type of Evaluation: The approval process described is for substantial equivalence of a physical device, which typically involves mechanical testing (e.g., bending strength, as mentioned in section 2) and comparison to existing predicate devices, not performance metrics like sensitivity, specificity, or reader studies relevant to AI/ML.
- Absence of AI/ML Specifics: There is no mention of algorithms, datasets, ground truth establishment by experts, or reader studies in the context of AI/ML performance.
The document discusses:
- Device Description: Merete Compression Screws (cannulated, self-drilling/self-tapping, dual pitched screws).
- Intended Use: Fracture fixation and reconstruction of various bones.
- Predicate Devices: K050346 NewDeal Stabilization Screw and K991151 Vilex/Duval/Orthex Cannulated Bone Screw.
- Substantial Equivalence Argument: Based on similar indications for use, materials (Ti-6Al-4V), and technological characteristics (core diameter, thread diameter, cannulation), and therefore presumed similar bending strength.
If you have a document describing an AI/ML medical device, I would be happy to help extract the requested information.
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1 510(k) Summary
Submitted by:
Merete Medical GmbH Alt Lankwitz 102, 12247 Berlin, Germany
SEP - 2 2009
FDA Registration Number:
3002949614
Contact Person:
Jörg Mietzner Merete Medical, Inc. 49 Purchase Street Rye, New York 10580 Phone: 914 967 1532
Device Name:
Merete Compression Screws
21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener
Product Code:
HWC
Proposed Regulatory Class: Class II
Device Description:
Device Classification:
Merete Compression Screws are cannulated, self-drilling/self-tapping, dual pitched screws with a threaded head which can be countersunk into the bone. The screws are provided in the diameters 3.0 mm, 4.3 mm and 6.5 mm in various lengths and are available in Titanium alloy (Ti-6Al-4V).
Intended use:
Merete Compression Screws are indicated for fracture fixation and reconstruction of various bones, including
- osteotomies in the foot (as Hallux Valgus treatment) or hand.
- arthrodesis in hand, foot or ankle surgery, -
- fixation of bone fragments in long bones or small bone fractures. -
The size of the chosen screw should be adapted to the specific indication.
Predicate Device:
Screws 3.0 mm and 4.3 mm: K050346 NewDeal Stabilization Screw
Screw 6.5 mm: K991151 Vilex/Duval/Orthex Cannulated Bone Screw
Substancial Equivalence:
Merete Compression Screws are similar to legally marketed predicate device listed above in that they share similar indications for use, are manufactured from similar materials and incorporate similar technological characteristics.
Merete Medical GmbH
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2 Bending Strength Rationale
The referenced predicate devices in K050346 and K991151 are similar in their dimensions to the Merete Compression Screws 3.0, 4.3 and 6.5 mm as they present a similar core diameter, thread diameter as well as a similar cannulation.
As the predicate devices are manufactured from similar materials (Ti-6Al-4V) too, the bending strength of the Merete Compression Screws 3.0, 4.3 and 6.5 mm can be supposed as similar as well.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Merete Medical, Inc. % Mr. Jörg Mietzner 49 Purchase Street Rye, New York 10580
SEP = 8 2009
Re: K091798
Trade/Device Name: Merete Compression Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: August 20, 2009 Received: August 24, 2009
Dear Mr. Mietzner:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Jörg Mietzner
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
Barbara Buchum
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 1
Indications for Use
510(k) Number (if known): K091798
Device Name: Merete Compression Screws
Indications for Use:
Merete Compression Screws are indicated for fracture fixation and reconstruction of various bones, including
- osteotomies in the foot (as Hallux Valgus treatment) or hand, -
- arthrodesis in hand, foot or ankle surgery, 1
- fixation of bone fragments in long bones or small bone fractures. -
The size of the chosen screw should be adapted to the specific indication.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
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) | |
|---|---|
| (Division Sign-Off) | Outu for mxm |
| Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | K091798 |
Merete Medical GmbH
June 2009
Page 4 of 16
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.