(36 days)
The B-BOP® plate is intended for fixation of osteotomy of the basis of the first metatarsal. Examples include:
- Moderate to severe hallux valgus
- Hallux varus
Newdeal has developed a plate dedicated to the fixation of basal osteotomy of the 1st metatarsal by designing the B-BOP® plate which allow to meet at best the specifications of that kind of surgical procedure.
Characteristics of the plate have taken into account all the requirements associated with basal osteotomy:
- Plantar positioning to obtain the best stability and resistance and allowing to reduce bulk
- Anatomical shape adapted to the plantar curve of the 1st metatarsal (pre-bent), available in right or left side and in two angulations (5° and 10°) for medium or large deformation.
The B-BOP® plate is made from titanium alloy (Ti-6AI-4V ELI) and the part of the plate in contact with bone is sandblasted for a better adherence of the plate.
Plates and screws are also available which are color-coded for ease of identification.
Fixation of the plate is provided by four Snap-Off screws, already present with the HALL 0 -Fix system (cleared under K021626).
With the B-BOP® plate, screws are available in 2 diameters (2.7mm and 3.0mm) and in a length range from 14mm to 26mm (2 mm increment). The screws are provided sterile with the B-BOP® plate.
Here's an analysis of the provided text regarding the acceptance criteria and study for the B-BOP® plate, structured according to your request.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bending strength | "The B-BOP® plate meets our acceptance criteria." |
| Fatigue testing | "The B-BOP® plate meets our acceptance criteria." |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size used for the test set for either the bending strength or fatigue testing.
The data provenance (e.g., country of origin, retrospective/prospective) is also not specified for these tests. It can be inferred that the testing was conducted by or on behalf of Newdeal SAS, a French company, but the specific location of the testing is not stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This document describes mechanical testing (bending strength and fatigue testing) of a medical device (B-BOP® plate). Mechanical testing does not typically involve human experts to establish ground truth in the same way clinical studies or diagnostic AI algorithms do. Instead, performance is measured against engineering specifications and industry standards. Therefore, this section is not applicable to the type of study described.
4. Adjudication Method for the Test Set
As the study involves mechanical testing and not human interpretation or clinical outcomes, an adjudication method in the sense of expert consensus for ground truth is not applicable. The "adjudication" is inherent in the measurement and comparison against predefined engineering acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This document describes mechanical testing of a medical implant and does not involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not Applicable. This document details the mechanical testing of a physical medical device (a plate), not a software algorithm or AI.
7. The Type of Ground Truth Used
The ground truth for this study appears to be predetermined engineering specifications and industry standards for bending strength and fatigue life of bone fixation plates. The document states, "The B-BOP® plate meets our acceptance criteria," implying that these criteria (standards for mechanical performance) served as the "ground truth."
8. The Sample Size for the Training Set
Not Applicable. This document describes mechanical testing of a physical device. There is no "training set" in the context of an AI algorithm or statistical model.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no training set, the method of establishing its ground truth is irrelevant.
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K052152 p1/2
Image /page/0/Picture/1 description: The image shows the logo for Newdeal, an Integra LifeSciences Company. The logo features the word "newdeal" in bold, black font, with a circle to the left of the word. The circle has four black dots and one gray dot. Below the word "newdeal" is the text "An Integra LifeSciences Company".
SEP 1 3 2005
510(k) SUMMARY
Submitter's Name and Address A. Newdeal SAS 10, place d'Helvétie 69006 LYON FRANCE Tel .: +33 4 37 47 51 51 Fax: +33 4 37 47 51 52 ESTABLISHMENT REGISTRATION NUMBER: 9615741
Contact Person B.
Morgane GRENIER Regulatory and Clinical Affairs Manager Newdeal SAS 10, place d'Helvétie 69006 LYON FRANCE Tel: +33 4 37 47 51 51 Fax: +33 4 37 47 51 52
- ं Date Summary Prepared August 1, 2005
- Name of Device D. Proprietary Name: B-BOP® plate
Common Name: Plate, fixation, bone
Classification Name and Reference
Single/multiple component metallic fixation appliances and bone accessories (21 CFR 888.3030)
Device Product Code: HRS
Proposed Regulatory Class: Class II
Panel: Orthopedic
Device Description E.
In the case of significant deformities (Hallux Valgus, Hallux Varus) of the forefoot, the basal or proximal osteotomy is generally more indicated than the distal osteotomy allowing greater corrections of the 1st metatarsal.
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$\cos 2/52 \ p^{2}/_{2}$
Newdeal has developed a plate dedicated to the fixation of basal osteotomy of the 1st metatarsal by designing the B-BOP® plate which allow to meet at best the specifications of that kind of surgical procedure.
Characteristics of the plate have taken into account all the requirements associated with basal osteotomy:
- Plantar positioning to obtain the best stability and resistance and allowing to reduce bulk
- Anatomical shape adapted to the plantar curve of the 15 metatarsal । (pre-bent), available in right or left side and in two angulations (5° and 10°) for medium or large deformation.
The B-BOP® plate is made from titanium alloy (Ti-6AI-4V ELI) and the part of the plate in contact with bone is sandblasted for a better adherence of the plate.
Plates and screws are also available which are color-coded for ease of identification.
Fixation of the plate is provided by four Snap-Off screws, already present with the HALL 0 -Fix system (cleared under K021626).
With the B-BOP® plate, screws are available in 2 diameters (2.7mm and 3.0mm) and in a length range from 14mm to 26mm (2 mm increment). The screws are provided sterile with the B-BOP® plate.
F. Indications for Use
The B-BOP® plate is intended for fixation of osteotomy of the basis of the first metatarsal. Examples include:
- Moderate to severe hallux valgus -
- -Hallux varus
Substantial Equivalence G.
The B-BOP® plate is substantially equivalent in terms of design, material, indications for use and fixation with the following predicate devices:
| Arthrex | Small Fragment Plates and Screws | K040907 |
|---|---|---|
| Acumed | Congruent Bone Plate System | K012655 |
| Synthes | Modular Foot System | K001941 |
Comparison of Technological Characteristics H.
The technological characteristics of the B-BOP® plate are the same as the characteristics of predicate devices in terms of intended use and design. All of these plates have the following characteristics:
- Holed for screwed fixation -
- Made from Titanium alloy or stainless steel -
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- Equivalent size range -
- Intended to be implanted for fixation of osteotomies, including basal osteotomy of the metatarsal.
I. Summary of Studies
Bending strength test and fatigue testing have been carried out. The B-BOP® plate meets our acceptance criteria.
J. Conclusion
The B-BOP® plate is substantially equivalent to commercially marketed devices, the Arthrex Small Fragment Plates and Screws (K040907), the Acumed Congruent Bone Plate System (K012655) and the Synthes Modular Foot System (K001941).
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
SEP I 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Newdeal SAS c/o Ms. Judith E. O'Grady Integra Lifesciences 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K052152 Trade/Device Name: B-BOP® plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: August 1, 2005 Received: August 9, 2005
Dear Ms. O'Grady:
We have reviewed your Section 510(k) premarket notification of intent to market the device w for have 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 haf our d 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. Judith E. O'Grady
This letter will allow you to begin marketing your device as described in your Section 510(k) I his icter will anow you to ough mating of substantial equivalence of your device to a legally premarket notification: "The PDF intellight 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 If you desire specific at not 10-10-10-120. Also, please note the regulation entitled, Colliation of Compulars as (21 the Part 807.97). You may obtain Misoranding of reference to premessionsibilities under the Act from the Division of Small other general 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,
signature
or Mark N. Melkerson Acting 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):
s2152
Device Name: B-BOP® plate
Indications For Use:
The B-BOP® plate is intended for fixation of osteotomy of the basis of the first metatarsal. Examples include:
- Moderate to severe hallux valgus -
- Hallux varus -
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
signature
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
14052152 510(k) Number_
§ 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.