(99 days)
The OS2®-V Varisation Staples are indicated for Akin type osteotomies.
The OS2®-V Varisation Staple is a metallic staple with two self- drilling tips. The treatment with a varisation staple allows, after possible treatment of the second ray, to correct the valgus deformation of the first ray and to recreate a square or Greek foot. Two types of staples are available depending on the bone surface.
Sizes: The OS2®-V Varisation Staple is available in various angles (90° and 26°) and interaxis (8mm and 10mm).
Material: The OS2®-V Varisation Staple is manufactured from stainless steel 316LVM, according to ISO 5832-1 and ASTM F138. It does not have any coating.
Single use: The OS2®-V Varisation Staple is designed for single use only.
Sterilization: The OS2®-V Varisation Staple is supplied sterile, using gamma irradiation.
Place of use: The OS2®-V Varisation Staple is indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained.
The provided text is a 510(k) Summary for a medical device called the "OS2®-V Varisation Staple." This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove acceptance criteria for an AI/algorithm-based device.
Therefore, many of the requested categories for AI/algorithm performance criteria (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or cannot be extracted from this document, as it describes a physical orthopedic implant.
Here's an attempt to answer the relevant questions based on the provided text, while also noting where information is not present or applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the OS2®-V Varisation Staple are primarily based on demonstrating substantial equivalence to existing predicate devices (Integra / Newdeal SOLUSTAPLE (K991566) and Memometal Varisation staple (K070033)). This equivalence is established across several characteristics, summarized below. The "reported device performance" in this context refers to showing that the OS2®-V Varisation Staple matches or is comparable to the predicate devices in these aspects.
| Acceptance Criteria (based on predicate equivalence) | Reported Device Performance (OS2®-V Varisation Staple) |
|---|---|
| Intended Use & Indications for Use | Indicated for Akin type osteotomies, which is identical to both predicate devices. |
| Design | Metallic staple with two self-drilling tips, available in straight and angle designs, manufactured from 1mm diameter wire. This design is similar to both predicate devices. |
| Size Range | Available in 8mm and 10mm interaxis, 10mm leg length, 26° and 90° angulation options. This size range is equivalent to both predicate devices. |
| Material | Manufactured from stainless steel 316LVM, according to ISO 5832-1 and ASTM F138. This is similar to the predicate devices which use stainless steel 316L, according to ISO 5832-1 and ASTM F138. The document states "similar raw material." |
| Mechanical Properties | Compliant with standard ISO 8827 “Implants for surgery – staples with parallel legs for orthopaedic use – general requirements”, similar to predicate devices. The document implies testing was done to ensure compliance with this standard, leading to the conclusion of similar mechanical properties. While specific test results are not detailed in this summary, the statement "The OS2®-V Varisation Staple has similar intended use and mechanical properties when compared to the Integra / Newdeal SOLUSTAPLE (K991566) and Memometal Varisation staple (K070033). Indeed, they are all compliant with standard ISO 8827" indicates that compliance with mechanical standards for bone staples serves as a key acceptance criterion. |
| Sterilization | Supplied sterile, using gamma irradiation. (Implied acceptability based on common practice for implants). |
| Single Use | Designed for single use only. (Implied acceptability based on common practice for implants). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as it pertains to a physical implant, not an AI/algorithm. The submission focuses on substantial equivalence based on material, design, indications, and compliance with general mechanical standards for orthopedic staples. Clinical trial data or specific human subject test sets are not detailed in this 510(k) summary for this type of device.
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)
This information is not applicable/not provided for a physical medical implant device. Ground truth, expert consensus, and qualifications of medical readers are relevant for diagnostic AI algorithms, not for physical staples.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided for a physical medical implant device. Adjudication methods are relevant for evaluating diagnostic performance, typically of AI tools or human readers.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable/not mentioned in this document. Such studies are conducted for diagnostic devices (often AI-assisted) to evaluate the impact on human reader performance, which is not the subject of this 510(k) for a surgical staple.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not mentioned because the device is a physical surgical staple, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided for a physical medical implant. The "ground truth" for this device revolves around its physical and mechanical properties, material biocompatibility, and its intended use aligning with established surgical procedures, rather than diagnostic accuracy. Its performance is evaluated against engineering standards (e.g., ISO 8827) and comparison to legally marketed predicate devices for similar applications.
8. The sample size for the training set
This information is not applicable/not provided as the device is a physical surgical staple, not an AI/algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided as the device is a physical surgical staple, not an AI/algorithm requiring a training set and corresponding ground truth.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26, 2015
IN2Bones SAS % Norman F. Estrin, Ph.D. Estrin Consulting Group LLC 9109 Copenhaver Drive Potomac, Maryland 20854
Re: K143323 Trade/Device Name: OS2®-V Varisation Staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: January 18, 2015 Received: January 29, 2015
Dear Dr. Estrin:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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Page 2 – Norman F. Estrin, Ph.D.
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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004_Indications for Use.pdf
K143323 page 1/1
Indications for Use
| 510(k) Number (if known): | Not yet assigned |
|---|---|
| Device Name: | OS2®-V Varisation Staple |
| Indications For Use: | The OS2®-V Varisation Staples are indicated for Akin type osteotomies. |
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image shows the logo for IN2BONES. The logo is inside of a gray oval shape. The text "IN2BONES" is in white, except for the number "2" which is in orange. There is a white swoosh on the left side of the oval.
005_510(k) Summary.pdf
510(k) SUMMARY For In2Bones OS2®-V Varisation Staple
| Sponsor identification | In2Bones SAS28 chemin du Petit Bois69130 Ecully – FrancePhone: +33.4.72.29.26.26Fax: +33.4.72.29.26.29 |
|---|---|
| Establishment registration number | 3010470577 |
| Date of preparation | 20th February 2015 |
| Contact person | Norman F. Estrin, Ph.D.Estrin Consulting Group LLC9109 Copenhaver DrivePotomac, MD 20854Phone: (301) 279-2899Email: estrin@yourFDAconsultant.com |
| Authorized Agent in the United States | Norman F. Estrin, Ph.D.Estrin Consulting Group LLC9109 Copenhaver DrivePotomac, MD 20854Phone: (301) 279-2899Email: estrin@yourFDAconsultant.com |
| Proprietary Name | OS2®-V Varisation Staple |
| Common name | Bone Varisation staple |
| Device classification regulation | 21 CFR 888.3030: Single/multiple component metallic bonefixation appliances and accessoriesClass II |
| Device Product Code and Panel | JDR: staple, fixation, bone87 orthopedics |
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| Device Description | The OS2®-V Varisation Staple is a metallic staple with two self- drilling tips. The treatment with a varisation staple allows, after possible treatment of the second ray, to correct the valgus deformation of the first ray and to recreate a square or Greek foot. Two types of staples are available depending on the bone surface.Sizes: The OS2®-V Varisation Staple is available in various angles (90° and 26°) and interaxis (8mm and 10mm).Material: The OS2®-V Varisation Staple is manufactured from stainless steel 316LVM, according to ISO 5832-1 and ASTM F138. It does not have any coating.Single use: The OS2®-V Varisation Staple is designed for single use only.Sterilization: The OS2®-V Varisation Staple is supplied sterile, using gamma irradiation.Place of use: The OS2®-V Varisation Staple is indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained. |
|---|---|
| Predicate Devices | Integra / Newdeal SOLUSTAPLE (K991566)Memometal Varisation staple (K070033) |
| Indications for use: | The OS2®-V Varisation Staples are indicated for Akin type osteotomies |
COMPARISON OF THE INDICATIONS FOR USE WITH THE PREDICATE DEVICES:
As with the predicate devices, the OS2°-V Varisation Staple is indicated for surgical implantation longer than 30 days in the fixation of bone fractures or for bone reconstruction.
| 510k number | K991566 | Substantial equivalence discussion | |
|---|---|---|---|
| manufacturer | In2Bones | Integra / Newdeal | |
| Name of device | OS2®-V Varisation Staple | SOLUSTAPLE | OS2®-V Varisation Staple has exactly the same indications for use as the SOLUSTAPLE: “Akin type osteotomy” |
| Indications for use | The OS2®-V Varisation Staples are indicated for Akin type osteotomies. | The SOLUSTAPLE® is indicated for Akin type osteotomy |
| 510k number | K070033 | Substantial equivalencediscussion |
|---|---|---|
| manufacturer In2Bones | Memometal Varisationstaple | OS2®-V Varisation Staplehas exactly the same |
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| Name ofdevice | OS2®-V VarisationStaple | Varisation staple | indications for use as theMemometal Varisation |
|---|---|---|---|
| Indicationsfor use | The OS2®-VVarisation Staples areindicated for Akintype osteotomies. | The MemometalVarisation Staple isindicated for Akin typeosteotomy | staple: “Akin typeosteotomy” |
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| Comparison ofTechnologicalcharacteristics | The technological characteristics of the OS2®-V VarisationStaple are the same as the characteristics of predicate devices interms of intended use and design. All these implants have thefollowing features:- Insertion into bone: The OS2®-V Varisation Staple and allpredicate devices are intended for surgical implantationinto bone for longer than 30 days.- Indications for use: The OS2®-V Varisation Staple hassimilar indications for use when compared to the Integra /Newdeal SOLUSTAPLE (K991566) and MemometalVarisation staple (K070033): all are indicated for Akintype osteotomies.- Design: The OS2®-V Varisation Staple has similar design,when compared to the Integra / Newdeal SOLUSTAPLE(K991566) and Memometal Varisation staple (K070033):all are staples with self-drilling tips, available in straightand angle designs, manufactured from 1mm diameterwire.- Equivalent size range: The OS2®-V Varisation Staple hassimilar size range, when compared to the Integra /Newdeal SOLUSTAPLE (K991566) and MemometalVarisation staple (K070033): all are staples available in8mm and 10mm interaxis, 10mm leg length, 26° and 90°angulation options.- Material: OS2®-V Varisation Staple has similar rawmaterial, when compared to the Integra / NewdealSOLUSTAPLE (K991566) and Memometal Varisationstaple (K070033): all are manufactured from stainlesssteel 316L, according to ISO 5832-1 and ASTM F138.The OS2®-V Varisation Staple has similar intended useand mechanical properties when compared to the Integra /Newdeal SOLUSTAPLE (K991566) and MemometalVarisation staple (K070033). Indeed, they are allcompliant with standard ISO 8827 “Implants for surgery –staples with parallel legs for orthopaedic use – generalrequirements”. |
|---|---|
| SubstantialEquivalence Summary | The OS2®-V Varisation Staple has similar technologicalcharacteristics when compared to the predicate devices.Substantial equivalence discussion is provided here below: |
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| 510k number | K991566 | K070033 | |
|---|---|---|---|
| manufacturer | In2Bones | Integra / Newdeal | Memometal Varisation staple |
| Name of device | OS2®-V Varisation Staple | SOLUSTAPLE | Varisation staple |
| Use | Single use | Single use | Single use |
| Fixation | Bone | Bone | Bone |
| Indications for use | The OS2®-V Varisation Staples are indicated for Akin type osteotomies | The SOLUSTAPLE® is indicated for Akin type osteotomy | The Memometal Varisation Staple is indicated for Akin type osteotomy |
| Design | Staple with self-drilling tips, available in straight and angle designs, manufactured from 1mm diameter wire. | Staple with self-drilling tips, available in straight and angle designs, manufactured from 1mm diameter wire. | Staple with self-drilling tips, available in straight and angle designs, manufactured from 1mm diameter wire. |
| size | available in 8mm and 10mm interaxis, 10mm leg length26° and 90° angulation options | available in 8mm and 10mm interaxis, 10mm leg length26° and 90° angulation options | available in 8mm and 10mm interaxis, 10mm leg length26° and 90° angulation options |
| Raw material | stainless steel 316L, according to ISO 5832-1 and ASTM F138 | stainless steel 316L, according to ISO 5832-1 and ASTM F138 | stainless steel 316L, according to ISO 5832-1 and ASTM F138 |
Substantial Equivalence Comparison and Discussion
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indications of the OS2®-V Varisation Staples are substantially equivalent to the predicate devices identified in the 510(k) submission. No new materials or processes are used in the development of this implant.
The OS2®-V Varisation Staples are acceptable for the application.
§ 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.