(312 days)
No
The description focuses on the mechanical components and function of an external fixator system, with no mention of AI or ML. The performance studies are mechanical tests, not algorithm performance evaluations.
Yes
The device is described as an external fixator system used for bone stabilization in fractures, bone defects, and limb lengthening, which aligns with the definition of a therapeutic device.
No
The device is an external fixator system used for bone stabilization and does not perform diagnostic functions like identifying or characterizing a disease or condition.
No
The device description explicitly lists various hardware components (rings, rods, pins, etc.) that form the external fixation system. There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Bfix® Orthopedic External Fixator Systems is described as an external fixation system used to stabilize bone fractures. It involves implanting pins into bone and connecting them to external components. This is a surgical/mechanical intervention performed directly on the patient's body, not a test performed on a sample outside the body.
- Intended Use: The intended use is for bone stabilization in the lower limbs for fractures, defects, and limb lengthening. This is a therapeutic and structural application, not a diagnostic test.
Therefore, the Bfix® Orthopedic External Fixator Systems falls under the category of a surgical or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Bfix® Orthopedic External Fixator Systems is intended to be used on adults patients for bone stabilization in the lower limbs.
The indication for use includes:
- open or closed fractures in long bones;
- bone defects or reconstructive procedure
- limb lengthening
Product codes
KTT
Device Description
The Bfix® Orthopedic External Fixator Systems is an external fixation system that consists of various components used for the external stabilization of bone fractures. The external fixators components includes ring, connecting rods, thread rods, posts, couplings, telescopic struts, static struts, washer, clamps and pins that combined to construct different frame configuration which is appropriate for each specification application. The metallic bone pin is implanted into bone and then connected with the external components to form a rigid construct which holds the bone fragments rigidly in place.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs
Indicated Patient Age Range
adults patients
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)
The mechanical performance of the proposed device has been conduct tests according to ASTM F1541-17 and ASTM F543-17. The following tests were carried out:
- Static bending test, ●
- Static torsion test, ●
- Single bending test ●
- Bending fatique test ●
- Axial pull-out test
- Rotational torque test ●
- Self-tapping performance .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Aike (Shanghai) Medical Instrument Co., Ltd. Hongying Gu OC Manager B320/B321/B322/B323, No. 1128, South Huicheng Road, Jiading Industrial District Shanghai, 200071 CHINA
Re: K200491
Trade/Device Name: Bfix® Orthopedic External Fixator Systems Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT Dated: December 3, 2020 Received: December 9, 2020
Dear Hongying Gu:
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 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
1
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 medical devices and radiation-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,
Ting Song, Ph.D., R.A.C. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K200491
Device Name
Bfix® Orthopedic External Fixator Systems
Indications for Use (Describe)
The Bfix® Orthopedic External Fixator Systems is intended to be used on adults patients for bone stabilization in the lower limbs.
The indication for use includes:
-
open or closed fractures in long bones;
-
bone defects or reconstructive procedure
-
limb lengthening
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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K200491-510(k) summary
I. Submitter
Aike (Shanghai) Medical Instrument Co., Ltd. B320, B321, B322, B323, No. 1128, South Huicheng Road, Jiading Industrial District, Shanghai, China
Contact person: Gu Hongying Position: QC Manager Phone: +086-13564123520 Fax: +086-021-69522433 E-mail: 314363362@qq.com Preparation date: 2020-9-08
II. Proposed Device
| Trade Name of Device: | Bfix® Orthopedic External Fixator Systems |
|---|---|
| Common name: | External Fixator Systems |
| Regulation Number: | 21 CFR 888.3030 |
| Regulatory Class: | Class II |
| Product code: | KTT |
| Review Panel | Orthopedic |
III. Predicate Devices
Predicate device 1
510(k) Number: K113770 Product Code: KTT Classification: 21 CFR 888.3030 Trade Name: Orthofix Galaxy Fixation System Common Name: External Fixation Device and Accessories Manufacturer: Orthofix Srl
IV. Device description
The Bfix® Orthopedic External Fixator Systems is an external fixation system that consists of various components used for the external stabilization of bone fractures. The external fixators components includes ring, connecting rods, thread rods, posts, couplings, telescopic struts, static struts, washer, clamps and pins that combined to construct different frame configuration which is appropriate for each specification
4
application. The metallic bone pin is implanted into bone and then connected with the external components to form a rigid construct which holds the bone fragments rigidly in place.
V. Indication for use
The Bfix® Orthopedic External Fixator Systems is intended to be used on adults patients for bone stabilization in the lower limbs.
The indication for use includes:
- open or closed fractures in long bones;
- bone defects or reconstructive procedure
- limb lengthening
VI. Comparison of technological characteristics with the predicate devices
The principle of operation for the proposed device and the predicated device is stabilization of bones through fixation with pin clamps to an external fixation frame built with rod. The Bfix® Orthopedic External Fixator System is similar to legally marketed predicated devices in that they are manufactured from similar materials, are of structurally similar size, strength and stiffness, and incorporated similar methods of assembly and adjustable.
VII. Non-Clinical Testing
The mechanical performance of the proposed device has been conduct tests according to ASTM F1541-17 and ASTM F543-17. The following tests were carried out:
- Static bending test, ●
- Static torsion test, ●
- Single bending test ●
- Bending fatique test ●
- Axial pull-out test
- Rotational torque test ●
- Self-tapping performance .
VIII. Clinical Testing
It is not applicable.
IX. Conclusion
The proposed device has the same indication for use, has similar design features and technological characteristic as the predicate device. Performance testing data
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demonstrates that the proposed device is safety and effectiveness as the predicated device. Accordingly, the proposed device is substantially equivalent to the predicate device.