(46 days)
No
The device description details a mechanical pin protection system with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used to protect protruding ends of wires and does not directly provide therapeutic benefit to the patient's condition.
No
Explanation: The Electro-Spec Steri-Caps are described as devices used to protect protruding ends of wires in surgical procedures. Their function is purely protective and mechanical, not to diagnose or detect medical conditions or diseases.
No
The device description clearly details physical components made of metal (pin balls, set screws, driver) and a surface treatment, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Electro-Spec Steri-Caps are described as physical components (pin balls and set screws) intended to be placed on protruding wires from bone during surgical procedures. Their purpose is to protect the user and the wire.
- Lack of Biological Sample Analysis: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's health status.
The device is a surgical accessory used for physical protection during orthopedic procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Electro-Spec Steri-Caps are indicated for use in protection of protruding ends of wires. Examples of procedures that may leave protruding wires include:
- Osteotomies or arthrodesis of fractures management in the foot or hand
- Fixation of small bone fragments, in long bones or small bones fractures
Product codes
HTY
Device Description
The Electro-Spec Steri-Caps are indicated for use in protection of protruding ends of wires. Examples of procedures that may leave protruding wires include:
- Osteotomies or arthrodesis of fractures management in the foot or hand
- Fixation of small bone fragments, in long bones or small bones fractures- Fixation of small bone fragments, in long bones or small bones fractures
Steri-Caps are comprised of a pin ball intended to be placed on the end of a wire or pin protruding from bone, secured with a setscrew, and used to protect the user and wire.
The pin balls are offered in diameters of 8.95mm and 12.13mm, and designed to accommodate K-wires or pins less than 1.65mm in diameter. The set screws are offered in lengths of 3.30mm. The longer of the set screws is referred to as the Long Set Screw. Each set screw is threaded with an M4 x 0.7 outer thread, and has a 2.50mm diameter hexagonal cannulation for use with the 2.5mm driver. The 2.5mm driver is used to set the set screw once the pin or wire has been placed through the pin ball. Each pin ball and set screw is offerent materials, namely 6A4V ELI Titanium per ASTM F136, 304 SST, or 17-4 SST, Heat Treat to condition H900. The component is then treated with an ES (Electro-Spec) Surface Treatment, intended to add hardness, scratch resistance, hydrophobicity, and wear resistance. The ES Surface Treatment is a 4-to-15-micron thick, electroplated alloy that can be plated on numerous types of surfaces providing better scratch-resistance, corrosion, and tarnish properties than conventional surfaces can provide due to its hardness and hydrophobic properties. A satin finish is provided on all components.
All components and the instrument are offered non-sterilization before use
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot, Hand, Long Bones, Small Bones (for fixation of fractures)
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
No non-clinical testing was performed.
No clinical testing was performed.
Key Metrics
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
August 14, 2023
Image /page/0/Picture/1 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Electro-Spec, Inc % Guthrie Carolyn VP of Regulatory Affairs Kapstone Medical 520 Elliot Street Charlotte, North Carolina 28202
Re: K231905
Trade/Device Name: Electro-Spec Steri-Caps Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: June 28, 2023 Received: June 29, 2023
Dear Guthrie Carolyn:
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 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,
Image /page/1/Picture/6 description: The image contains the text "Colin O'neill -S". The text is arranged in two lines, with "Colin" on the first line and "O'neill -S" on the second line. The text is black and the background is white.
Colin O'Neill, M.B.E. 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) K231905
Device Name Electro-Spec Steri-Caps
Indications for Use (Describe)
Electro-Spec Steri-Caps are indicated for use in protection of protruding ends of wires. Examples of procedures that may leave protruding wires include:
-
Osteotomies or arthrodesis of fractures management in the foot or hand
-
Fixation of small bone fragments, in long bones or small bones fractures
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
21 CFR 807.92(a)(1)
Prepared on: 2023-08-11
Contact Details
| Applicant Name | Electro-Spec, Inc |
|---|---|
| Applicant Address | 1800 Commerce Parkway Franklin IN 46131 United States |
| Applicant Contact Telephone | +1-317-739-0924 |
| Applicant Contact | Mr. Jeff Smith |
| Applicant Contact Email | jsmith@electro-spec.com |
| Correspondent Name | Kapstone Medical |
| Correspondent Address | 520 Elliot Street Charlotte NC 28202 United States |
| Correspondent Contact Telephone | +1-704-737-2866 |
| Correspondent Contact | Ms. Guthrie Carolyn |
| Correspondent Contact Email | cguthrie@kapstonemedical.com |
Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | Electro-Spec Steri-Caps |
|---|---|
| Common Name | Smooth or threaded metallic bone fixation fastener |
| Classification Name | Pin, Fixation, Smooth |
| Regulation Number | 888.3040 |
| Product Code | HTY |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K203698 | CoLink® Sfx Implant System | HTY |
| K192768 | Eisertech, LLC Temporary Fixation Pins | HTY |
Device Description Summary
21 CFR 807.92(a)(4)
The Electro-Spec Steri-Caps are indicated for use in protection of protruding ends of wires. Examples of procedures that may leave protruding wires include:
- Osteotomies or arthrodesis of fractures management in the foot or hand
- Fixation of small bone fragments, in long bones or small bones fractures- Fixation of small bone fragments, in long bones or small bones fractures
Steri-Caps are comprised of a pin ball intended to be placed on the end of a wire or pin protruding from bone, secured with a setscrew, and used to protect the user and wire.
The pin balls are offered in diameters of 8.95mm and 12.13mm, and designed to accommodate K-wires or pins less than 1.65mm in
4
diameter. The set screws are offered in lengths of 3.30mm. The longer of the set screws is referred to as the Long Set Screw. Each set screw is threaded with an M4 x 0.7 outer thread, and has a 2.50mm diameter hexagonal cannulation for use with the 2.5mm driver. The 2.5mm driver is used to set the set screw once the pin or wire has been placed through the pin ball. Each pin ball and set screw is offerent materials, namely 6A4V ELI Titanium per ASTM F136, 304 SST, or 17-4 SST, Heat Treat to condition H900. The component is then treated with an ES (Electro-Spec) Surface Treatment, intended to add hardness, scratch resistance, hydrophobicity, and wear resistance. The ES Surface Treatment is a 4-to-15-micron thick, electroplated alloy that can be plated on numerous types of surfaces providing better scratch-resistance, corrosion, and tarnish properties than conventional surfaces can provide due to its hardness and hydrophobic properties. A satin finish is provided on all components.
All components and the instrument are offered non-sterilization before use
Intended Use/Indications for Use
Electro-Spec Steri-Caps are indicated for use in protection of protruding ends of wires. Examples of procedures that may leave protruding wires include:
- Osteotomies or arthrodesis of fractures management in the foot or hand
- Fixation of small bone fragments, in long bones or small bones fractures
Indications for Use Comparison
The Indications for Use are the same between the subject device and the primary predicate device (K203698).
Technological Comparison
Steri-Caps has the same intended use as the primary predicate device, and the following same technological characteristics: * Insertion of a pin or K-wire through the device, with a locking mechanism to hold the pin or K-wire in place
Any technical differences, do not result in new questions of safety or effectiveness, and include the following:
-
- A difference in shape with the intended use achieved with both designs
- A difference in materials, although the is achieved with both designs and the material of the subject device meets the requirements of ISO 10993-1
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
No non-clinical testing was performed.
No clinical testing was performed.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)