(87 days)
No
The device description and intended use are for mechanical fixation pins, and there is no mention of AI, ML, or any software-driven functionality.
No
The device is used for the "fixation of bone fractures, fusion of joints or bone reconstructions, or as guide pins for insertion of other implants," which are therapeutic applications, but its primary function is mechanical support and guiding, not to treat or cure a disease itself, but to aid in the healing process. While it serves a role in patient care, it's more of a surgical accessory or support rather than a device with inherent therapeutic properties.
No
The device is described as temporary fixation pins used for the fixation of bone fractures, fusion of joints, or bone reconstruction, or as guide pins for insertion of other implants. Its intended use is mechanical support or guidance, not the diagnosis of a condition.
No
The device description clearly states the device is made of physical materials (stainless steel or titanium alloy) and is a physical implant (pins). It does not describe any software component.
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 Eisertech, LLC Temporary Fixation Pins are described as being used for the fixation of bone fractures, fusion of joints, bone reconstructions, and as guide pins for other implants. These are all procedures performed directly on the patient's body (in vivo).
- No Mention of Specimen Testing: The description and intended use do not involve the analysis of any biological specimens.
Therefore, based on the provided information, the Eisertech, LLC Temporary Fixation Pins are a surgical implant/instrument used in orthopedic procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Eisertech, LLC Temporary Fixation Pins are indicated for the following:
- guide wire for osteosynthesis implants
- accessories for external fixation (Steinmann Pin)
- application as implant according to the principles of fracture management
Product codes (comma separated list FDA assigned to the subject device)
JDW, HTY
Device Description
The Eisertech, LLC Temporary Fixation Pins are indicated for the fixation of bone fractures, fusion of joints or bone reconstructions, or as guide pins for insertion of other implants. The Temporary Fixation Pins are offered in a variety of lengths, diameters, tip styles, and threading. The devices are made of either 17-4 stainless steel per ASTM F138 or titanium alloy (Ti-6Al-4V-ELI) per ASTM F136. The devices are delivered non-sterile and have to be sterilized before use. After fracture healing the implants have to be removed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones/bone fractures, joints
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)
The subject Temporary Fixation pins are manufactured from the same materials, fall within the geometry and dimensions, and share the same intended use as previously cleared for the predicate device. Therefore, it is expected that they would perform equivalent to the predicate devices. Thus, performance testing is not necessary and was not performed on the subject device.
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.
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.
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
§ 888.3040 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
December 26, 2019
EiserTech, LLC % Dawn Norman Executive Vice President MRC/X, LLC 6075 Poplar Avenue Memphis, Tennessee 38119
Re: K192768
Trade/Device Name: Temporary Fixation Pins Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JDW. HTY Dated: September 28, 2019 Received: September 30, 2019
Dear Dawn Norman:
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
1
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 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 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,
Ronald P. Jean, Ph.D. Director (Acting) 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)
K192768
Device Name Temporary Fixation Pins
Indications for Use (Describe)
Eisertech, LLC Temporary Fixation Pins are indicated for the following:
-
guide wire for osteosynthesis implants
-
accessories for external fixation (Steinmann Pin)
-
application as implant according to the principles of fracture management
| 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."
3
510(k) Summary
Temporary Fixation Pin September 28, 2019
| Company: | Eistertech, LLC
9988 Hibert Street Suite 302
San Diego, CA 92131 |
|--------------------------------|-------------------------------------------------------------------------------------|
| Establishment
Registration: | 3009381326 |
| Primary Contact: | Dawn Norman
Phone: 618-604-3064 |
| Company Contact: | Lukas Eisermann
Phone: 888-262-2817 |
| Trade Name: | Temporary Fixation Pin |
| Common Name: | Pin, Fixation, Smooth
Pin, Fixation, Threaded |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener) |
| Panel: | 87- Orthopedic |
| Product Code: | JDW, HTY |
| Primary
Predicate Device: | aap Implantate AG aap Wire Bone / K-Wire; Cerciage Wire,
Steinmann Pin (K131459) |
| Reference
Predicate Device: | Eisertech, LLC Cervical Plate System Instruments (K190565) |
Device Description:
The Eisertech, LLC Temporary Fixation Pins are indicated for the fixation of bone fractures, fusion of joints or bone reconstructions, or as guide pins for insertion of other implants. The Temporary Fixation Pins are offered in a variety of lengths, diameters, tip styles, and threading. The devices are made of either 17-4 stainless steel per ASTM F138 or titanium alloy (Ti-6Al-4V-ELI) per ASTM F136. The devices are delivered non-sterile and have to be sterilized before use. After fracture healing the implants have to be removed.
4
Indications for Use:
Eisertech, LLC Temporary Fixation Pins are indicated for the following:
- guide wire for osteosynthesis implants
- accessories for external fixation (Steinmann Pin)
- application as implant according to the principles of fracture management
Substantial Equivalence:
The subject Eisertech, LLC Temporary Fixation Pin is substantially equivalent to predicate aap Implantate AG's aap Wire Bone / K-Wire; Cerclage Wire, Steinmann Pin (K131459, S.E. 10/17/2013) with the surface treatment being identical to the surface treatment cleared for use in instruments in reference device Eisertech, LLC's Cervical Plate System Instruments (K190565, S.E. 05/31/2019).
The Indications for Use, Materials, and Geometry for predicate devices are all similar to those of the subject device. The surface treatment is identical to the surface treatment applied to the reference device Eisertech, LLC Cervical Plate Instruments.
Performance Testing:
The subject Temporary Fixation pins are manufactured from the same materials, fall within the geometry and dimensions, and share the same intended use as previously cleared for the predicate device. Therefore, it is expected that they would perform equivalent to the predicate devices. Thus, performance testing is not necessary and was not performed on the subject device.
Conclusion:
There are no substantial differences between the Temporary Fixation Pins and the predicate device with respect to intended use and technological characteristics, including basic design, base materials of manufacture, mechanical properties, and intended effect.
Therefore, the Temporary Fixation Pins can be found substantially equivalent to the cited predicate, as it does not raise new questions of safety and effectiveness.