(51 days)
| HBS-Mini (2.5mm) | HBS Standard (3.0mm) |
|---|---|
| Scaphoid fractures | Scaphoid fractures |
| Lunate fractures | Carpal fractures and non-unions |
| Capitate | Capitellum fractures |
| Trapezial fractures | Metacarpal fractures |
| Metacarpal and metatarsal fractures | Phalangeal fractures |
| Phalangeal fractures | Distal radial fractures |
| Radial head fractures | Radial head fractures |
| Ulnar styloid fractures | Ulnar styloid fractures |
| Osteo-chondral | Small joint fusions |
| Small joint fusions | Humeral head fractures |
| Glenoid fractures | |
| Intercarpal fusions | |
| Interphalangeal fractures | |
| Metatarsal osteotomies | |
| Tarsal fusions | |
| Malleolar fractures | |
| Patellar fractures | |
| Osteo-chondral fractures |
The BioPro HBS screw is designed for hand, foot and small bone fragment repairs or fusions. Uses include osteotomy fixation, joint arthrodesis or post traumatic fragment repair. The BioPro HBS screw is made of titanium in compliance with ASTM F136-02a. The screw is similar to other screws available on the market. The HBS screw is cannulated and comes in two diameters, 2.5mm and 3.0mm. Each screw is available in several lengths ranging from 6mm up to 40mm in length. The screws have a Torx driving head. The new versions of the screw will be provided sterile.
The provided text describes a 510(k) submission for a medical device (HBS Headless Bone Screw) and primarily focuses on proving substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study designed to prove the device meets specific performance metrics in the way that would typically be described for a diagnostic or AI-driven medical device.
The "performance testing" mentioned refers to engineering rationale regarding the screw's material and design, particularly torsional strength, in relation to ASTM F-543 ("Standard Specification and Test Methods for Metallic Medical Bone Screw"). The primary "studies" described relate to sterilization validation.
Therefore, many of the requested elements for describing acceptance criteria and a study cannot be directly extracted from the provided document.
However, I can extract and interpret the information that is present regarding the device's characteristics and the rationale for its approval.
Here's a breakdown based on the categories you provided, indicating where information is present versus not present:
Acceptance Criteria and Device Performance Study (Based on Submitted Information)
The document's primary "study" is a demonstration of substantial equivalence, with particular focus on the unchanged design (except for length), material, and sterilization process. It does not present specific quantitative performance metrics or acceptance criteria for clinical efficacy or diagnostic accuracy, as it is a bone screw and its performance is more related to mechanical properties and sterilization.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material: Titanium ASTM F136-02a compliance | Device is made of Titanium ASTM F136-02a. |
| Design: Cannulated with Torx drive, two diameters (2.5mm, 3.0mm) | Design is identical to predicate device, with added lengths (up to 40mm). |
| Torsional Strength: No change from predicate device | Engineering rationale provided: diameters are unchanged, implying no change to torsional strength. (Specific values not provided) |
| Sterility Assurance Level (SAL): 10^-6 | Sterility validated to 10^-6 SAL via Ethylene Oxide (EtO) using AAMI Overkill Method. |
| EO and ECH Residuals: Compliance with ANSI/AAMI/ISO 10933-7 | EtO residuals testing protocol implemented as per standard (specific measured values not provided). |
| Packaging: Compliance with medical packaging requirements | Double blister system with Tyvek® Lids certified and tested per current requirements. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of a clinical performance study as defined for AI or diagnostic devices. Performance is largely based on engineering testing and sterilization validation. Specific sample sizes for engineering tests (e.g., how many screws tested for torsional strength, or how many sterilization cycles validated) are not provided in this summary.
- Data Provenance: Not applicable in the context of clinical data for software. The "data" pertains to engineering specifications, material compliance, and sterilization validation results, which would be generated internally from laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. "Ground truth" in this context would relate to objective measurements of mechanical properties or sterility, not expert interpretation of clinical data.
4. Adjudication Method for the Test Set
- Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is a medical device (bone screw), not a diagnostic tool or AI software. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Engineering Specifications: Compliance with ASTM F136-02a for material and, by engineering rationale, maintenance of torsional strength based on unchanged diameter.
- Sterilization Validation Standards: Compliance with ANSI/AAMI/ISO 10933-7 and ANSI/AAMI ST 27-1988 for sterility assurance and residuals.
- Predicate Device Equivalence: The ultimate "ground truth" for the 510(k) submission is demonstrating substantial equivalence to the legally marketed predicate device (K020791 for the original design, and K991197 for additional lengths) in terms of safety and effectiveness, given the minor modifications (sterilization and increased length).
8. The Sample Size for the Training Set
- Not applicable. This is not an AI or machine learning device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" described in the 510(k) summary is not a single, comprehensive clinical trial for performance metrics typical of AI or diagnostic devices. Instead, it comprises several components:
- Engineering Rationale: An engineering rationale was provided to demonstrate that because the screw diameters remain unchanged, there is no change to the torsional strength from the predicate device, which is made of the same ASTM-compliant titanium (F136-02a). This addresses the mechanical performance aspect.
- Sterilization Validation Study: A complete summary of studies related to sterilization (Attachment "B" of the submission) was included. This validation was performed using the Ethylene Oxide (EtO) method with an AAMI Overkill Method to achieve a Sterility Assurance Level (SAL) of 10^-6. EtO and ECH residuals were tested to meet ANSI/AAMI/ISO 10933-7 standards.
- Packaging Validation: Packaging (double blister system with Tyvek® Lids) was certified and tested according to current medical packaging requirements.
- Risk Analysis: A complete risk analysis for sterilization and packaging (Attachment "A" of the submission) was provided.
- Device Comparison: A tabular comparison highlighting the similarities in material and design, and the modifications (sterilization, length increase) relative to predicate devices (Vilex 510k 991197, Osteomed K010783, and the original HBS 510k 020791).
The conclusion of the submission states that "Based on these studies we believe the subject device is safe and effective" and that the device is "substantially equivalent to the predicate devices" due to the unchanged design (except for length), material, and new sterilization. The FDA's 510(k) clearance (K101030) confirmed this substantial equivalence.
{0}------------------------------------------------
K10103D
510k Summary
Date Prepared: May 12, 2010
Company Information
| Sponsor/Manufacturer: | BioPro , Inc. |
|---|---|
| Address: | 17 Seventeenth St.Port Huron, MI 48060 |
| Owner/Operator: | Pat Pringle |
| ERN: | 1833506 |
| Contact: | David Mrak |
| Title: | Director of Product Development |
| Phone: | (810) 982-7777 |
| Email: | mrakd@bioproimplants.com |
| Contract sterilizer: | Tri-State Hospital Supply |
| Address: | 301 CatrellHowell, MI 48843 |
| ERN: | 1824619 |
| Contact: | Karen Kowalczyk |
| Title: | QA Director |
| Phone: | 517-545-5400 |
JUN - 3 2010
Representative/Consultant
N/A
Device Information
HBS (Headless Bone Screw) Proprietary Name: Smooth or threaded metallic bone fixation fastener Common Name: Classification Name: Screw Fixation Bone Orthopedic (OR) Classification Panel: Class II per 21 CFR §888.3390 Regulatory Class: Product Code: HWC K020791; 510k 991197 Predicate Device:
Performance and Voluntary Standards
No Performance Standards applicable to this device have been adopted under Section 514 of the Act.
Intended Use
, lof $\bar{s}$
{1}------------------------------------------------
The intended use and indications of the modified device are the intended uses and indications for the unmodified device however use in the skull has been omitted. The device is being offered sterile as opposed to non-sterile and additional lengths have been added.
Sterilization Information
| Method: | Ethylene oxide (EtO), fixed chamber |
|---|---|
| Sterility Assurance Level: | 10-6 |
| Validation Method: | AAMI Overkill Method |
| Sterilization Site: | Tri-State Hospital Supply Howell, MIERN: 1824619 |
| EO and ECH residuals: | The EtO residuals testing protocol requires residuals as perANSI/AAMI/ISO 10933-7 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals, paragraph 4.3.1Permanent Contact Devices; as per this standard, the averagedaily dose of EO to the patient shall not exceed 0.1 mg/day, andthe maximum EO dose shall not exceed 20 mg in the first 24hours, 60 mg in the first 30 days, and 2.5 g in a lifetime. For ECH,the average daily dose shall not exceed 2 mg/day, and themaximum ECH dose shall not exceed 12 mg in the first 24 hours,60 mg in the first 30 days, and 50 g in a lifetime. Provided themeasured EO residual is below 0.1 mg, the release rates cannotexceed these limits; similarly, if the measured ECH residual isbelow 2 mg, the release rates cannot exceed these limits. |
| Packaging Information: | Peelable Tyvek® Lids, double Blister, in a cardboard box, andtamper resistant outer labels. |
Original unmodified predicate device:
The original unmodified device was known as the HBS. The device was submitted under 510k 020791. The device was submitted by Millennium Medical Technologies, Inc. and was distributed by them. BioPro has obtained the rights to the 510k and has been legally marketing the device since 2008.
Description:
The BioPro HBS screw is designed for hand, foot and small bone fragment repairs or fusions. Uses include osteotomy fixation, joint arthrodesis or post traumatic fragment repair. The BioPro HBS screw is made of titanium in compliance with ASTM F136-02a. Titanium is a biocompatible material that is readily available and commonly used in implanted medical devices. The screw is similar to other screws available on the market. The HBS screw is cannulated and comes in two diameters, 2.5mm and 3.0mm. Each screw is available in several lengths ranging from 6mm up to 40mm in length the original system was available up to 30mm lengths and the original screws
{2}------------------------------------------------
were provided non sterile. The new versions of the screw will be provided sterile. The screws have a Torx driving head.
Device Comparison:
| Feature | Substantially Equivalent Device(s) | BioPro HBS Screw |
|---|---|---|
| Material | Vilex 510k 991197Titanium ASTM F136-02aHBS 510k 020791 | Titanium ASTM F136-02a |
| Sizes | Vilex 2.0-6.5mmOsteomed K010783 2.0-2.4mmHBS (original) 2.5-3.0mm up to30mm lengths | 2.5-3.0mm 6mm to40mm lengths |
| Design | Vilex: Cannulated with hexagonaldriveOsteomed: Cannulated withCruciform Drive | Cannulated with Torxdrive |
| Sterilization | Vilex: provided non-sterileOsteomed: Provided non-sterileHBS Original | Provided sterile viaETO Sterilization |
Summary of modifications:
The original screws were provided non-sterile and were available in two diameters, 2.5mm and 3.0mm with lengths up to 30mm
The modified screws in this submission will now be provided sterile and the lengths will increase to 40mm with no changes to the diameter of the screw.
Performance testing: The implant is made of titanium to the ASTM standards that are recognized consensus standards of the FDA. There is an ASTM standard F-543 entitled: "Standard Specification and Test Methods for Metallic Medical Bone Screw" An engineering rational is included in this submission in regards to this specification.
Device Information:
Intended Use:
This device:
-
- has been previously submitted to the FDA for identical or different intended uses. Under 510k 0207091
-
- is not currently being reviewed for different intended uses by the same or a different branch within the ODE
2 f 5
{3}------------------------------------------------
-
- Has not been previously cleared by the FDA for different intended uses.
Indications:
| HBS-Mini (2.5mm) | HBS Standard (3.0mm) |
|---|---|
| Scaphoid fractures | Scaphoid fractures |
| Lunate fractures | Carpal fractures and non-unions |
| Capitate | Capitellum fractures |
| Trapezial fractures | Metacarpal fractures |
| Metacarpal and metatarsal fractures | Phalangeal fractures |
| Phalangeal fractures | Distal radial fractures |
| Radial head fractures | Radial head fractures |
| Ulnar styloid fractures | Ulnar styloid fractures |
| Osteo-chondral | Small joint fusions |
| Small joint fusions | Humeral head fractures |
| Glenoid fractures | |
| Intercarpal fusions | |
| Interphalangeal fractures | |
| Metatarsal osteotomies | |
| Tarsal fusions | |
| Malleolar fractures | |
| Patellar fractures | |
| Osteo-chondral fractures |
Contraindications:
-
- Comminuted bone surface that would mitigate against screw placement.
-
- Pathologic conditions of bone such as osteopenia which would impair the ability to securely fix the staple.
-
- Foreign body sensitivity to metals specifically titanium. Where material sensitivity is suspected, appropriate tests should be made prior to implantation.
Materials:
Titanium (ASTM F136-02a)
Packaging/Sterilization Information:
The packaging will consist of a double blister system; both blisters will use a tyvek backing and a polyethylene tray. A "peel" type opening will allow reliable removal of the product inside the sterile field. This packaging will be certified and tested according to current medical packaging requirements. All components will be sterilized using the ethylene oxide gas sterilization method and validated per ANSI/AAMI ST 27-1988 prior to marketing the device. See section 14 for sterilization validation information. With an SAL of 10 .
{4}------------------------------------------------
Labeling
Draft labeling for this device is included.
Verification Activities
Engineering rational provided for testing of the screws. No changes were made to the diameters so there would be no changes to the torsional strength. A complete summary of the studies as they relate to the sterilization are included in Attachment "B". of the submission. Also included is the complete risk analysis for the sterilization and packaging in Attachment "A". Based on these studies we believe the subject device is safe and affective
Conclusion:
The primary change for this special 510k submission was the change for non-sterile screws to sterile screws. The design of the screw is unchanged from our predicate device with the exception of the length increase of 10mm. Not only are the original sizes substantially equivalent to our existing device, they are identical in design and have not changed. The additional lengths were added and the 510k 991197 was used as the predicate for those changes. Considering that the design has not changed and the parts are now sterile we believe that we have shown the device to be substantially equivalent to the predicate devices.
p. 5 of 5
{5}------------------------------------------------
Image /page/5/Picture/11 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem that resembles an abstract caduceus or a symbol representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
BioPro, Inc. % Mr. David Mrak Director of Product Development 2929 Lapeer Road Port Huron, Michigan 48060
JUN - 3 2010
Re: K101030
Trade/Device Name: HBS Headless Bone Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 17, 2010 Received: May 17, 2010
Dear Mr. Mrak:
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 (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
{6}------------------------------------------------
Page 2 - Mr. David Mrak
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 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" (2.1.CFR 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 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.
Sincerely yours,
Rabara Buchmp
Mark N. Mel Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
Indications for Use
K1010 30 510(k) Number (if known):
Device Name: BioPro HBS (Headless Bone Screw)
Indications for Use:
| HBS-Mini (2.5mm) | HBS Standard (3.0mm) |
|---|---|
| Scaphoid fractures | Scaphoid fractures |
| Lunate fractures | Carpal fractures and non-unions |
| Capitate | Capitellum fractures |
| Trapezial fractures | Metacarpal fractures |
| Metacarpal and metatarsal fractures | Phalangeal fractures |
| Phalangeal fractures | Distal radial fractures |
| Radial head fractures | Radial head fractures |
| Ulnar styloid fractures | Ulnar styloid fractures |
| Osteo-chondral | Small joint fusions |
| Small joint fusions | Humeral head fractures |
| Glenoid fractures | |
| Intercarpal fusions | |
| Interphalangeal fractures | |
| Metatarsal osteotomies | |
| Tarsal fusions | |
| Malleolar fractures | |
| Patellar fractures | |
| Osteo-chondral fractures |
Prescription Use__X (Per 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)
Onette for myn
(Division Sign off)
Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K/01030
§ 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.