(258 days)
Not Found
No
The device description and intended use clearly describe a mechanical pin for membrane fixation, with no mention of software, algorithms, or any AI/ML related terms.
No.
The device is described as a pin for fixation of membranes, which is a mechanical function, not a therapeutic one. It facilitates a surgical procedure, but does not directly treat a disease or condition itself.
No
The device description indicates that the MP Pins are used for the fixation of membranes to bone, which is a therapeutic or reconstructive function, not a diagnostic one. They do not infer medical conditions or diseases.
No
The device description clearly states it is a "Pin with a flat head," which is a physical hardware component. The intended use also describes a physical fixation process.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the physical fixation of membranes to bone during surgical procedures. This is a mechanical function performed directly on the patient's body.
- Device Description: The device is described as a pin with a flat head, a physical object used for fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a structural purpose.
N/A
Intended Use / Indications for Use
The MP Pins without thread, flat head are indicated for the fixation of apical membrane ends at the local bone in order to avoid micromobility of the membrane. They allow for the fixation of resorbable and non-resorbable membranes.
Product codes (comma separated list FDA assigned to the subject device)
DZL
Device Description
Pin with a flat head for the fixation of resorbable and non-resorbable membranes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
apical membrane ends at the local bone
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 following performance data were provided in support of the substantial equivalence determination:
-Biocompatibility testing: Cytotoxicity testing was performed per ISO 10993-5. The results confirm the biological safety of the subject device.
-Sterilization validation was performed per ISO 17664 and ISO 17665-1
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.
Not Found
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
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
October 17, 2024
Hager & Meisinger GmbH Melanie Otto Regulatory Affairs Manager Hansemannstr. 10 Neuss. 41468 GERMANY
Re: K240321
Trade/Device Name: MP Pin flat without thread Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw Or Wire Regulatory Class: Class II Product Code: DZL Dated: September 16, 2024 Received: September 16, 2024
Dear Melanie Otto:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Sherrill Lathrop Blitzer
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240321
Device Name MP Pin without thread, flat head
Indications for Use (Describe)
The MP Pins without thread, flat head are indicated for the fixation of apical membrane ends at the local bone in order to avoid micromobility of the membrane. They allow for the fixation of resorbable and non-resorbable membranes.
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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4
510(k) Traditional K240321 - MP Pin without thread, flat head 510(k) summary
Contact Details
| Applicant Name |
|---|
| Applicant Address |
| Applicant Contact Telephone |
| Applicant Contact |
| Applicant Contact Email |
| Date prepared |
Hager & Meisinger GmbH Hansemannstr. 10 Neuss 41468 Germany +492132012206 Ms. Melanie Otto RA@meisinger.de 10/17/2024
Device Name
| Device Trade Name | MP Pin without thread, flat head |
|---|---|
| Common Name | Intraosseous fixation screw or wire |
| Classification Name | Screw, Fixation, Intraosseous |
| Regulation Number | 872.4880 |
| Product Code(s) | DZL |
Primary Predicate Device
| Predicate # Predicate | K130682 |
|---|---|
| Trade Name Product | Meisinger MEITAC, Meisinger Master-Pin-Control |
| Code | DZL |
Device Description Summary
Pin with a flat head for the fixation of resorbable and non-resorbable membranes.
Intended Use/Indications for Use
The MP Pins without thread, flat head are indicated for the fixation of apical membrane ends at the local bone in order to avoid micromobility of the membrane. They allow for the fixation of resorbable and non-resorbable membranes.
Indications for Use Comparison
The indications for use of the subject device "MP Pin without thread, flat head" are identical to the indications for use of the predicate device "Meisinger MEITAC, Meisinger Master-Pin-Control".
Technological Comparison
The subject device and predicate devices are composed of the same titanium alloy (3.7165 6Al-4V ELI) and have identical principles of operation (i.e., the fixation of resorbable and non-resorbable membranes). There are differences in device
5
510(k) Traditional K240321 - MP Pin without thread, flat head 510(k) summary
dimension due to the difference in pin head geometry (subject device has a flat head vs. hexagonal connection of the predicate device) which does not raise new risks with regard to safety or performance, as determined by internal validation based on the FDA-recognized standard IEC 62366-1 ).
Performance Data
The following performance data were provided in support of the substantial equivalence determination:
-Biocompatibility testing: Cytotoxicity testing was performed per ISO 10993-5. The results confirm the biological safety of the subject device.
-Sterilization validation was performed per ISO 17664 and ISO 17665-1
Conclusions
The subject device and the predicate devices have identical intended use and technological characteristics and are made of identical materials. No new risks are identified, thus we concluded that the subject device is substantially equivalent to the predicate device.