(286 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a simple orthopedic pin, with no mention of AI/ML or data processing.
No.
The device is used for stabilizing bone, which is a supportive function, not a therapeutic one in the sense of actively treating or curing a disease or disorder. Its purpose is mechanical fixation rather than biological intervention or healing promotion.
No
The device description clearly states its intended use for "fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants," which are therapeutic or surgical functions, not diagnostic ones.
No
The device description clearly states it is a physical pin made of stainless steel, which is a hardware component. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states the device is an "Orthopedic Fixation Pin" used for "fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants." This is a surgical implant used within the body to provide structural support.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, performing tests on samples, or providing diagnostic information based on laboratory analysis.
The device described is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Orthopedic Fixation Pin is indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants.
Product codes
JDW
Device Description
The Orthopedic Fixation Pin is straight, partially threaded; and has trocar point on one end. The device is available in various diameters and lengths to accommodate the specific indication. The pins are made from stainless steel in accordance with ASTM F138-13.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The Orthopedic Fixation Pins are indicated for use in a hospital, or outpatient surgery center, where sterile field may be created and maintained.
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)
To verify that the Orthopedic Fixation Pin is substantially equivalent to the predicate device, representative samples of Orthopedic Fixation Pin were underwent a series of tests including bench testing (static pullout per ASTM F543, static torsion test per ASTM F1541, tensile testing), and biocompatibility testing (cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity, subchronic systemic toxicity pyrogenicity, genotoxicity, and carcinogenicity).
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
§ 888.3040 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.
0
April 14, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
Tinavi (Anhui) Medical Technologies Co., Ltd. Jianhua Jiang Quality Manager Building 5,Robot Industrial Base of TusCity, Jinxiu Avenue/Susong Road, Hefei, 230601 Cn
Re: K191803
Trade/Device Name: Orthopedic Fixation Pin Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: JDW Dated: January 13, 2020 Received: January 13, 2020
Dear Jianhua Jiang:
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
1
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 (QS) 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,
Colin O'Neill, M.B.E. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191803
Device Name Orthopedic Fixation Pin
Indications for Use (Describe)
Orthopedic Fixation Pin is indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants.
| 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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K191803 Page 1 of 4
510(K) Summary
I. SUBMITTER:
Tinavi (Anhui) Medical Technologies Co., Ltd. Building 5,Robot Industrial Base of TusCity, Jinxiu Avenue/Susong Road, Economic Development Zone, Hefei, Anhui Province, P.R.C. 230601 Tel: +86-551-65605200 Fax: +86-551-65605200
Contact Person: Jianhua Jiang Title:Quality Manager Phone: +86-551-65605200-8401 Email: Jiangjianhua@tinavi.com
Summary prepared: 06/20/2019
II. DEVICE
Name of Device: Orthopedic Fixation Pin Regulation Number: 21 CFR part 888.3040 Common Name: Smooth or threaded metallic bone fixation fastener Classification Panel: Orthopedic Regulatory Class: II Product Code: JDW
III. PREDICATE DEVICE
Primary predicate device: In2Bones® Kirschner wire (K153204)
IV. DEVICE DESCRIPTION
The Orthopedic Fixation Pin is straight, partially threaded; and has trocar point on one end. The device is available in various diameters and lengths to accommodate the specific indication. The pins are made from stainless steel in accordance with ASTM F138-13.
510(K)
4
V. INDICATIONS FOR USE
The Orthopedic Fixation Pin is indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The Orthopedic Fixation Pin and the In2Bones® Kirschner wire are to be used as fixation implants for bone fractures, joint fusion, bone reconstruction, or as guide pins for insertion of other implantable devices. Additionally, the Orthopedic Fixation Pin is similar to the In2Bones® Kirschner in regard to insertion, design, size ranges, and material.
| Item | Proposed Device
Orthopedic Fixation Pin | Predicate Device
In2Bones® Kirschner wire |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K number | TBD | K153204 |
| Classification | Class II | Class II |
| Product Code | JDW | HTY, JDW |
| Common name | Pin, Fixation, Threaded | Pin, Fixation, Smooth
Pin, Fixation, Threaded |
| Intended use | The Orthopedic Fixation Pins are intended to be used as fixation implants for bone fractures, joint fusion, bone reconstruction, or as guide pins for insertion of other implantable devices | The In2Bones® Kirschner wires are intended to be used as fixation implants for bone fractures, joint fusion, bone reconstruction, or as guide pins for insertion of other implantable devices |
| Indications for use | The Orthopedic Fixation Pins are indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants. The size of the Orthopedic Fixation Pins chosen should be adapted to the specific indication. | The In2Bones® Kirschner wires are indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants. The size of the In2Bones® Kirschner wire chosen should be adapted to the specific indication. |
| Duration of Use | Longer than 30 days | Longer than 30 days |
| Place of use | | |
| | The Orthopedic Fixation Pins are indicated for use in a hospital, or outpatient surgery center, where sterile field may be created and maintained. | The In2Bones® Kirschner wires are indicated for use in a hospital, or outpatient surgery center, where sterile field may be created and maintained. |
| Sizes | | |
| | The Orthopedic Fixation Pins are available in various diameters (1.1 mm to 2.5mm) and lengths (70mm to 300mm). | The In2Bones® Kirschner wire is available in various diameters (0.8mm to 2.5mm) and lengths (70mm to 300mm). |
| Material | | |
| | The Orthopedic Fixation Pins are manufactured from stainless steel (00Cr18Ni14Mo3) in accordance with ASTM F138-13. It does not have any coating. | The In2Bones® Kirschner wire is manufactured from stainless steel 316LVM, according to ISO 5832-1 and ASTM F138-13. It does not have any coating. |
| Design | | |
| | Orthopedic Fixation Pin is a stainless steel pin. The Orthopedic Fixation Pin is straight, partially threaded; and has trocar point on one end. The pins are available in various diameters and lengths. | The In2Bones® Kirschner wire is a metallic wire available in four point styles: sharp, partially threaded, lanceolate, both ends sharp. One part is fixed on standard surgical power tool equipment for insertion. |
| Single Use | Single use | Single use |
| Biocompatibility | Biocompatible | Biocompatible |
| Sterilization | The Orthopedic Fixation Pins are supplied non-sterile. The non-sterile Orthopedic Fixation Pins must be steam sterilized before use. | The In2Bones® Kirschner wire is supplied sterile and non-sterile. The sterile In2Bones® Kirschner wire is sterilized using gamma radiation. The non-sterile In2Bones® Kirschner wire must be steam sterilized before use. |
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510(K)
VII. PERFORMANCE DATA
Non-Clinical Performance Data
To verify that the Orthopedic Fixation Pin is substantially equivalent to the predicate device, representative samples of Orthopedic Fixation Pin were underwent a series of tests including bench testing (static pullout per ASTM F543, static torsion test per ASTM F1541, tensile testing), and biocompatibility testing (cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity, subchronic systemic toxicity pyrogenicity, genotoxicity, and carcinogenicity).
Clinical Performance Data
No data from human clinical studies have been included to support the substantial equivalence of the proposed device, Orthopedic Fixation Pin, as clinical studies are not required for this medical device.
VIII. CONCLUSION
The same intended use, the similarity in overall technological characteristics, and performance data result in that Orthopedic Fixation Pin are substantially equivalent to legally marketed device.