(27 days)
The KLS Martin Drill Free® MMF Screws is intended for use in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both.
The KLS-Martin Drill Free® MMF Screw provides temporary occlusal and fracture stabilization. These screws may be applied prior to or after exposure of the fracture.
Here's an analysis of the provided text regarding the acceptance criteria and study for the KLS Martin Drill Free® MMF Screw.
Unfortunately, the provided text does not contain any information about acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) summary and the FDA's clearance letter for the KLS Martin Drill Free® MMF Screw. It focuses on demonstrating substantial equivalence to predicate devices rather than providing performance data from a specific study against predefined acceptance criteria.
Therefore, I cannot populate most of the requested sections. Here's what I can extract from the provided text based on the limited information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Not specified in document |
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for test set: Not specified.
- Data provenance: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable as no specific study data or ground truth establishment is described in the provided document.
4. Adjudication Method for the Test Set
- Not applicable as no specific study data or adjudication is described in the provided document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, there is no mention of an MRMC study.
- Effect size of human reader improvement with AI vs. without AI assistance: Not applicable, as this is a medical screw, not an AI-assisted diagnostic device.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? No, there is no mention of a standalone performance study. This device is a physical medical implant, not an algorithm.
7. Type of Ground Truth Used
- Not applicable as no specific study data or ground truth is described in the provided document.
8. Sample Size for the Training Set
- Not applicable as no "training set" is relevant for this type of medical device submission.
9. How the Ground Truth for the Training Set Was Established
- Not applicable as no "training set" is relevant for this type of medical device submission.
Summary of Document's Content:
The provided documents describe the submission of a 510(k) premarket notification for the KLS Martin Drill Free® MMF Screw. The core of the submission is to demonstrate substantial equivalence to existing predicate devices based on:
- Identical intended use: For maxillomandibular fixation to stabilize fractures of the maxilla, mandible, or both.
- Similar application: Compared to other drill-free and anchorage systems.
- Key difference: The new device is "drill-free" (self-tapping), while its primary predicate required a pilot hole.
The FDA's clearance letter confirms their determination of substantial equivalence, allowing the device to be marketed. This type of submission relies on comparisons to already cleared devices rather than a de novo study with acceptance criteria for a novel device.
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OCT 1 8 2004 510(K) SUMMARY
:
| Submitter: | KLS-Martin, L.P.11239-1 St. Johns Industrial Parkway SouthJacksonville, FL 32246Phone: 904-641-7746Fax: 904-641-7378 |
|---|---|
| Contact Person: | Jennifer DamatoDirector RA/QA |
| Date of Summary: | 15 September 2004 |
| Device Name: | KLS Martin Drill Free® MMF Screw |
| Trade Name: | Drill Free® MMF Screw |
| Common Name: | Screw, Fixation, Intraosseous |
| ClassificationName and Number: | Intraosseous fixation screw or wire(CFR 872.4880) |
| Regulatory Class: | Class II |
| Predicate Devices: | KLS Martin MMF Screw (K980760) |
| Centre-Drive Drill-Free® Screw (K971297) | |
| SystemKLS-MartinOrthoAnchorage(K033483) | |
| Intended Use: | The KLS-Martin Drill Free® MMF Screw isintended for use in maxillomandibular fixationto provide stabilization of fractures of themaxilla, mandible, or both. |
| DeviceDescription: | The KLS-Martin Drill Free® MMF Screwprovides temporary occlusal and fracturestabilization. These screws may be appliedprior to or after exposure of the fracture. |
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Technological Characteristics:
Similarities to Predicate
The KLS-Martin Drill Free® MMF Screw is identical in intended use as the KLS Martin MMF Screw (K980760)
The KLS-Martin Drill Free® MMF Screw is identical in application as the Centre-Drive Drill-Free® Screw (K971297) and the KLS-Martin Ortho Anchorage System (K033483)
Differences to Predicate
The KLS Martin MMF Screw (K980760) requires a pilot hole to be drilled prior to implantation. The KLS-Martin Drill Free® MMF Screw is a self tapping screw that does not require a pilot hole prior to implantation.
Substantial Equivalence:
The KLS-Martin Drill Free® MMF Screw is substantially equivalent in intended use as the KLS Martin MMF Screw (K980760) and is substantially equivalent in application as the Centre-Drive Drill-Free® Screw (K971297) and the KLS-Martin Ortho Anchorage System (K033483)
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2004
Ms. Jennifer Damato Director, Regulatory Affairs Quality Assurance KLS-Martin, L.P. 11239-1 St. John's Industrial Parkway South Jacksonville, Florida 32246
Re: K042573
Trade/Device Name: KLS Martin Drill Free® MMF Screws Regulation Number: 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: September 15, 2004 Received: September 21, 2004
Dear Ms. Damato:
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 roleronood above and no 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 approvisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 11 1), 1 mean 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 Eederal Register.
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Page 2 - Ms. Damato
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualled of a substant is a complies with other requirements mean that FDA has made a decemination that 50ar administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by potisted to: positi of the Act or any rederal statutes and regulations, but not limited to: registration
You must comply with all the Act's requirements and processforms areating You must comply with an the Act STOC STORES (21 CFR Part 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gTD Part 830); and i and listing (21 CFR Fall 807), laboling (21 CFR 200), and 11 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 82), 542 of t requirements as set form in the quality of stems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your device to a This letter will anow you to begin manieting your device of your device to a a premarket nothleation. The PDA milling of sassification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your de roo on an also as a subscription of any and prease contact the Other or Ochiphants and (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Inay other general micriminatemational and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Ching-Ling, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
KLS Martin Drill Free® MMF Screws Device Name:
Indications For Use:
The KLS Martin Drill Free® MMF Screws is intended for use in The NEO Martin Drovide stabilization of fractures of the maxilla, mandible, or both.
Sueen Ruanez
(Division Sign-Off) (Division Sign-Oth), General Hospital, Infection Control, Dental Devices 510(k) Number:
V Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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§ 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.