(266 days)
No
The description focuses on the mechanical properties, materials, and physical design of a bone screw and its use with bone cement. There is no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are biomechanical, biocompatibility, sterility, and shelf-life, not related to AI/ML performance metrics.
Yes
The device is used for the treatment of fractures caused by trauma, osteoporosis, or tumors, indicating a therapeutic purpose.
No
Explanation: The device description and intended use clearly indicate that The Injection Pin is an implantable surgical device used for the treatment of fractures, not for diagnosing medical conditions. It is designed to be placed in the thoracolumbar region and used in combination with bone cement.
No
The device description explicitly states that the Injection Pin is a single piece of Titanium alloy and describes its physical characteristics and materials, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an implant used in combination with bone cement for the treatment of spinal fractures. This is a surgical intervention performed in vivo (within the body).
- Device Description: The description details a physical implant (a screw) made of titanium alloy, designed for surgical placement.
- Performance Studies: The performance studies focus on biomechanical properties, biocompatibility, sterility, and shelf-life – all relevant to an implantable medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue), diagnostic purposes, or any of the typical components or processes associated with in vitro diagnostics.
In summary, the device is a surgical implant, not a diagnostic tool used outside the body.
N/A
Intended Use / Indications for Use
The Injection Pin, is indicated for fractures caused by severe osteoporosis, trauma, and tumors of the thoracic/lumbar spine from T9-L5. Injection Pin is indicated for use in combination with PMMA bone cement (Teknimed F200) for the treatment of fractures caused by trauma, osteoporosis, or turnors in the thoracic/lumbar spine from T9-L5.
Product codes (comma separated list FDA assigned to the subject device)
NDN, LOD
Device Description
The Injection Pin is a single piece of Titanium alloy (Ti 6Al 4V) that complies with ISO 5832-3 and ASTM F136. It is a fenestrated screw that is cannulated along its entire length, with lateral holes along the body that do not interfere or affect the threads. The spherical head of the screw has an internal hexagon for firm coupling with the insertion screwdriver (REF IPST0007).
The Injection Pin implant is a medical device to be placed in the thoracolumbar region through a minimally invasive procedure. This device being cannulated and fenestrated permits the use, when applicable, for the introduction of approved PMMA (Teknimed F20®). It is available in both 5 and 6mm diameters and in lengths 31-61mm in 3mm increments.
The Injection Pin is easily seen Intra-Operatively as well as post-Op with good visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic/lumbar spine from T9-L5
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)
Biomechanical:
According to EN ISO 14602:2011 (ISO 14602:2010), intended uses are summarized in the following:
- fracture treatment of T9-L5 vertebras.
- tumor treatment of T9-L5 vertebras.
The device Injection Pin is intended in association with PMMA (Teknimed F20®) bone cement.
The Injection Pin device was subjected to mechanical testing and simulations. Injection Pin was tested at the Polytechnic University of Milan, Dept. of Structural Engineering Bending and torsional tests was performed applying the worst-case loading scenario.
Bone cement injection testing was conducted to verify that the injection pin is compatible with, and capable of, delivering Teknimed F20® cement under worst-case conditions.
In silico simulation in Labs of Politecnico di Milano was validated to perform 4 different scenarios in comparison with predicate device V-Strut. The in-silico approach was consistent with the biomechanical behavior of a representative osteoporotic vertebra after augmentation according to different force-displacement curves, stiffness, and maximum forces. The Injection Pin device demonstrated substantially equivalent biomechanical behavior to the predicate V-strut device.
Biocompatibility:
Biocompatibility testing was conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." Injection Pin was tested to be non-cytotoxic according to ISO 10993-1 – PART 5 Injection Pin was tested to be non-pyrogenic according to ISO 10993-1 ETO and ECH residual were performed after EO sterilization process. Comparison with "marketed device" Miniars Screws (K143596) to demonstrate the safety of manufacturing process.
Sterility:
Injection Pin is provided STERILE to the end user. This device is for single use only. Each device is sterilized by Ethylene Oxide in accordance with ISO 11135-1 Level (SAL) of 10-6
Shelf-life:
Injection Pin is released with a maximum shelf-life of 5 years from the date of sterilization. The validation was performed in compliance with the standard UNI EN ISO 11607-1:2009, UNI EN ISO 11607-2:2006, UNI EN 868:2009 (relevant sections), ASTM F 1980-07:2011, ASTM F 1608-00, ASTM F 1929-98, ASTM F 1886/ F 1886-M.
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
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
0
March 3, 2023
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 acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the acronym in a square and the name in a sans-serif font.
SLK Ortho LLC Lawrence Kluge COO 5883 RFD Long Grove, Illinois 60047
Re: K221697
Trade/Device Name: Injection Pin Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: NDN, LOD Dated: January 25, 2023 Received: January 26, 2023
Dear Lawrence Kluge:
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,
Sara S. Thompson -S
For
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K221697
Device Name Injection Pin
Indications for Use (Describe)
Indication
The Injection Pin, is indicated for fractures caused by severe osteoporosis, trauma, and tumors of the thoracic/lumbar spine from T9-L5. Injection Pin is indicated for use in combination with PMMA bone cement (Teknimed F200) for the treatment of fractures caused by trauma, osteoporosis, or turnors in the thoracic/lumbar spine from T9-L5.
Type of Use (Select one or both, as applicable)
| Residential Use (Part 61 CFR 901 Subpart B) | Commercial Use (61 CFR 901 Subpart C) |
|---|---|
| --------------------------------------------- | --------------------------------------- |
| | 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
Date last revision: March 3, 2023
I. SUBMITTER
SLK ORTHO LLC 5883 RFD Long Grove, IL 60047 Phone: (847) 630-1818 Email: SLK1818@aol.com Small Business Decision Number: SBD228450 FDA User Fee Organization Number: 664743
Official Correspondent
Lawrence Kluge SLK ORTHO LLC 5883 KED Long Grove, IL 60047 Phone: (847) 630-1818 Email: SLK1818@aol.com
Establishment Number
Small Business Decision Number: SBD228450 FDA User Fee Organization Number: 664743
II. DEVICE
Name of Device: Injection Pin Common/Usual Name: Injection Pin (Titanium Fenestrated Screw) Device Classification: Class II Regulation Number: 21 CFR 888.3027 Device Product Codes: NDN LOD
III. PREDICATE DEVICE
Hyprevention SAS Tradename: V-STRUT© (K191709)
Reference Device:
4
F20® (FDA registration number: K103433), Miniars Screw (FDA registration number K143596)
The Predicate Device V-STRUT© (K191709) has not been subject to any design related recall
IV. DEVICE DESCRIPTION
The Injection Pin is a single piece of Titanium alloy (Ti 6Al 4V) that complies with ISO 5832-3 and ASTM F136. It is a fenestrated screw that is cannulated along its entire length, with lateral holes along the body that do not interfere or affect the threads. The spherical head of the screw has an internal hexagon for firm coupling with the insertion screwdriver (REF IPST0007).
The Injection Pin implant is a medical device to be placed in the thoracolumbar region through a minimally invasive procedure. This device being cannulated and fenestrated permits the use, when applicable, for the introduction of approved PMMA (Teknimed F20®). It is available in both 5 and 6mm diameters and in lengths 31-61mm in 3mm increments.
The Injection Pin is easily seen Intra-Operatively as well as post-Op with good visualization.
V. INDICATIONS FOR USE
The Injection Pin is indicated for fractures caused by severe osteoporosis, trauma, and tumors of the thoracic/lumbar spine from T9-L5. Injection Pin is indicated for use in combination with PMMA bone cement (Teknimed F20®) for the treatment of fractures caused by trauma, osteoporosis, or tumors in the thoracic/lumbar spine from T9-L5.
| COMPARISON | INJECTION PIN | V STRUT© |
|---|---|---|
| CLASSIFICATION | CLASS II | CLASS II |
| PICTURES | Image: Injection Pin | Image: V Strut |
| REGULATION | 21 CFR 888.3027 | 21 CFR 888.3027 |
| PRODUCT CODE | NDN, LOD | NDN, LOD |
| INDICATIONS | Indicated for use in fractures caused by severe | |
| osteoporosis, trauma, and tumors of the | ||
| thoracic/lumbar spine from T9-L5. Indicated for | ||
| use in combination with PMMA bone cement | ||
| (Teknimed F20®). | Indicated for use in combination with | |
| PMMA bone cement (Teknimed F20®) for | ||
| the treatment of fractures caused by | ||
| trauma, osteoporosis, or tumors in the | ||
| thoracic/lumbar spine from T9-L5. | ||
| IMPLANT MATERIAL | Titanium alloy (Ti 6Al 4V) that complies with ISO | |
| 5832-3 and ASTM F136. | PEEK-OPTIMA™ Polymer LT1 | |
| (ASTM F2026) Tantalum markers. | ||
| IMPLANT SIZES | Dia. 5.0/6.0mm in lengths 31-61mm (3mm inc) | Pedicle access diameter: 5 mm |
| Stacked spiral diameter: 20 mm | ||
| Height: up to 15 mm | ||
| SINGLE USE | Yes | Yes |
| STERILE | Yes | Yes |
| CANNULATED | Yes | Yes |
| Instruments | Injection Pin Screwdriver | V-Strut Instrumentation kit |
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE
5
VII. PERFORMANCE DATA
Biomechanical
According to EN ISO 14602:2011 (ISO 14602:2010), intended uses are summarized in the following:
- fracture treatment of T9-L5 vertebras.
- tumor treatment of T9-L5 vertebras.
The device Injection Pin is intended in association with PMMA (Teknimed F20®) bone cement.
The Injection Pin device was subjected to mechanical testing and simulations. Injection Pin was tested at the Polytechnic University of Milan, Dept. of Structural Engineering Bending and torsional tests was performed applying the worst-case loading scenario.
Bone cement injection testing was conducted to verify that the injection pin is compatible with, and capable of, delivering Teknimed F20® cement under worst-case conditions.
In silico simulation in Labs of Politecnico di Milano was validated to perform 4 different scenarios in comparison with predicate device V-Strut. The in-silico approach was consistent with the biomechanical behavior of a representative osteoporotic vertebra after augmentation according to different force-displacement curves, stiffness, and maximum forces. The Injection Pin device demonstrated substantially equivalent biomechanical behavior to the predicate V-strut device.
Biocompatibility
Biocompatibility testing was conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." Injection Pin was tested to be non-cytotoxic according to ISO 10993-1 – PART 5 Injection Pin was tested to be non-pyrogenic according to ISO 10993-1 ETO and ECH residual were performed after EO sterilization process. Comparison with "marketed device" Miniars Screws (K143596) to demonstrate the safety of manufacturing process.
Sterility
Injection Pin is provided STERILE to the end user. This device is for single use only. Each device is sterilized by Ethylene Oxide in accordance with ISO 11135-1 Level (SAL) of 10-6
Shelf-life
6
Injection Pin is released with a maximum shelf-life of 5 years from the date of sterilization. The validation was performed in compliance with the standard UNI EN ISO 11607-1:2009, UNI EN ISO 11607-2:2006, UNI EN 868:2009 (relevant sections), ASTM F 1980-07:2011, ASTM F 1608-00, ASTM F 1929-98, ASTM F 1886/ F 1886-M.
VIII. SUBSTANTIAL EQUIVALENCE CONCLUSION STATEMENT
INJECTION PIN Implant (Ti 6AL 4V) compared to the predicate device V-STRUT© has demonstrated safety, effectiveness and performance as intended. Thus, a conclusion of substantial equivalence to the predicate device is supported in this submission.