(158 days)
No
The device description and performance studies focus on the material properties and mechanical performance of a degradable staple, with no mention of AI or ML.
Yes.
The device is indicated for fixation of arthrodesis and osteotomies, which are medical procedures performed to treat conditions and restore function, hence classifying it as a therapeutic device.
No
The device is described as a fixation implant used for arthrodesis and osteotomies, which are surgical procedures, not diagnostic processes.
No
The device description clearly states it is a physical fixation implant made of degradable poly (L-lactide) reinforced with continuous mineral fibers, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of arthrodesis and osteotomies in hand or foot surgery. This is a surgical implant used directly on the patient's anatomy.
- Device Description: The device is described as a "fixation implant" made of degradable materials, designed to be used with surgical tools.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples like blood, urine, or tissue outside of the body to diagnose or monitor medical conditions. This device is a surgical implant used within the body for structural support during healing.
N/A
Intended Use / Indications for Use
The OSSIOfiber® Staple is indicated for fixation of arthrodesis, osteotomies in hand or foot surgery in the presence of appropriate brace and/or immobilization.
The number and size of the OSSIOfiber® Staples must be adapted to the indication.
Product codes (comma separated list FDA assigned to the subject device)
MNU
Device Description
The OSSIOfiber® Staple is a fixation implant made of degradable poly (L-lactide) (PLDLA) reinforced with continuous mineral fibers. OSSIOfiber® implants have been shown to be biocompatible. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made of minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.
The OSSIOfiber® Staples are supplied sterile, for single patient use only, and non-pyrogenic. They are available in several sizes: 11-25 mm bridge lengths, and 15-22 mm leg lengths.
The OSSIOfiber® Staples are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Static bending, bending fatigue and pull-out testing were performed as per ASTM F564-17 to verify the bending strength and stiffness, bending fatique strength, and pull-out fixation properties of the OSSIOfiber® Staple. Static bending and bending fatigue were compared to those of the primary predicate device (K153395). Pull-out testing was compared to those of the K181180 reference device. All testing were done initially and following in-vitro degradation. The in-vitro degradation profile was characterized.
Biocompatibility for the implants was established primarily based on the referenced ISO 10993 data from the previously cleared reference devices (K181180, K190652, K193660, K201803) as well as a rationale. A rationale was provided to support the MR safe labeling of the implant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
OS2®-C Compression Staple (K153395)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
OSSIO® Pin Product Family (K181180), OSSIOfiber® Hammertoe Fixation System (K190652, K201803), OSSIOfiber® Compression Screw (K193660)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
January 21, 2022
OSSIO Ltd. % David McGurl Director, Regulatory Affairs MCRA, LLC 803 7th Street NW Washington, District of Columbia 20001
Re: K212594
Trade/Device Name: OSSIOfiber® Staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MNU Dated: January 10, 2022 Received: January 10, 2022
Dear David McGurl:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Limin Sun, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212594
Device Name OSSIOfiber® Staple
Indications for Use (Describe)
The OSSIOfiber® Staple is indicated for fixation of arthrodesis, osteotomies in hand or foot surgery in the presence of appropriate brace and/or immobilization.
The number and size of the OSSIOfiber® Staples must be adapted to the indication.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
OSSIOfiber® Staple
Submitter
Ossio Ltd.
8 HaTochen Street, Caesarea, Israel, 3079861
Phone: +972-4-9986600 Facsimile: +972-4-9986601 Contact Person: Taly Lindner Date Prepared: Jan 16, 2022
Name of Device: OSSIOfiber® Staple
Common or Usual Name: Staple, Absorbable
Classification Name: Single/multiple component metallic bone fixation appliances and accessories
Regulatory Class: Class II, 21 C.F.R. § 888.3030
Product Code: MNU
Predicate Devices
OS2®-C Compression Staple (K153395) - Primary Predicate
Reference Devices
OSSIO® Pin Product Family (K181180) OSSIOfiber® Hammertoe Fixation System (K190652, K201803) OSSIOfiber® Compression Screw (K193660)
Device Description
The OSSIOfiber® Staple is a fixation implant made of degradable poly (L-lactide) (PLDLA) reinforced with continuous mineral fibers. OSSIOfiber® implants have been shown to be biocompatible. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made of minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.
The OSSIOfiber® Staples are supplied sterile, for single patient use only, and non-pyrogenic. They are available in several sizes: 11-25 mm bridge lengths, and 15-22 mm leg lengths.
The OSSIOfiber® Staples are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations.
4
Indications for Use
The OSSIOfiber® Staple is indicated for fixation of arthrodesis, osteotomies, and fractures in hand or foot surgery in the presence of appropriate brace and/or immobilization.
The number and size of the OSSIOfiber® Staples must be adapted to the indication.
Summary of Technological Characteristics
The OSSIOfiber® Staples have intended use, and similar indications for use, principles of operation and design characteristics as the primary predicate device the OS2®-C Compression Staple (K153395).
The OSSIOfiber® Staples' material composition as well as the manufacturing and sterilization methods are the same as that of the cleared reference devices the OSSIO® Pin Product Family (K181180), OSSIOfiber® Hammertoe Fixation System (K190652, K201803) and OSSIOfiber® Compression Screw (K193660). Both subject device and the primary predicate device are supplied sterile. The OSSIOfiber® Staple is sterilized by EtO whereas the primary predicate is sterilized by Gamma. The subject device is made of OSSIOfiber® material while the primary predicate is made of PEEK. The OSSIOfiber® Staple has slightly longer leg and bridge lengths compared to the primary predicate. Although there are differences with regards to material, shape and size compared to the primary predicate, mechanical testing demonstrated at least equivalent performance both initially and after in vitro degradation. Any differences between OSSIOfiber® Staple and its primary predicate device do not raise different questions of safety and effectiveness.
Non-Clinical Data
Static bending, bending fatigue and pull-out testing were performed as per ASTM F564-17 to verify the bending strength and stiffness, bending fatique strength, and pull-out fixation properties of the OSSIOfiber® Staple. Static bending and bending fatigue were compared to those of the primary predicate device (K153395). Pull-out testing was compared to those of the K181180 reference device. All testing were done initially and following in-vitro degradation. The in-vitro degradation profile was characterized.
Biocompatibility for the implants was established primarily based on the referenced ISO 10993 data from the previously cleared reference devices (K181180, K190652, K193660, K201803) as well as a rationale. A rationale was provided to support the MR safe labeling of the implant.
Conclusions
The OSSIOfiber® Staple is as safe and effective as its primary predicate device, the OS2®-C Compression Staple (K153395). The OSSIOfiber® Staples have the same intended use, and similar indications for use, principles of operation, and design characteristics as the primary predicate device the OS2®-C Compression Staple (K153395). Material composition is the same as the reference devices (K181180, K193660, K190652, K201803). The minor differences do not alter the intended surgical use of the implant and do not affect its safety and effectiveness when used as labeled. Non-clinical testing data demonstrate that the OSSIOffber® Staple is at least as safe and effective as the primary predicate device. Thus, the OSSIOfiber® Staple is substantially equivalent.