(116 days)
The KLS Martin SonicWeld RX (Resorb-X) is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, plates, screws and pins may be used in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of the craniofacial or mandibular areas. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation. The KLS Martin SonicWeld RX (Resorb-X) is not intended for areas with active or latent infection or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not intended for use in the spine. The SonicWeld Rx pins are designed only to be inserted with the SonicWeld Rx Sonotrode device.
The SonicWeld RX (Resorb-X) is identical to RESORB-X® SF (K051236) which consists of RESORB-X® Pins made of Poly (D, L) -Lactide-Acid (PDLLA) of various diameters and lengths that are implanted utilizing ultrasonic force generated by an ultrasonic unit that causes a phase transition in the pin, allowing the pin to adapt to the previously drilled pilot hole in the surgical site and utilize the micro undercuts of the bone for retention. The RESORB-X® SF pins are designed to be used in conjunction with RESORB-X® Resorbable Plating System plates (K011590).
The provided document is a 510(k) summary for the KLS Martin SonicWeld RX (Resorb-X) device. It is a premarket notification for a medical device seeking substantial equivalence to existing devices. This type of document focuses on establishing equivalence to predicate devices based on intended use and technological characteristics, rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or performance study would for a novel device or AI algorithm.
Therefore, many of the requested categories related to clinical study design, acceptance criteria, and AI performance evaluation are not applicable or cannot be answered from this document.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
Not applicable. This document does not establish new acceptance criteria for performance; instead, it asserts "substantial equivalence" to predicate devices based on chemical composition, implantation method, and general intended use. There are no specific performance metrics or acceptance criteria reported for the SonicWeld RX (Resorb-X) that would be presented in a table like this, as it is claiming to be identical or very similar to already cleared devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document does not describe a clinical study with a test set of patients/data. It is a regulatory submission for device clearance based on equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no test set or ground truth establishment relevant to an AI algorithm or diagnostic performance in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication process described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document is for a medical device (bone plates, screws, pins), not an AI algorithm, and therefore, an MRMC study is not relevant to its clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is established for device performance in the context of diagnostic accuracy, as this is not a diagnostic device nor does it involve the analysis of data. The "ground truth" for this submission is based on the previously established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI algorithm.
Summary of Relevant Information from the Document:
While the document doesn't fit the mold of an AI algorithm study, it does contain information about how the device's "acceptance" (i.e., regulatory clearance) was achieved based on equivalence, which is a form of "proof" in the regulatory context.
- Device: SonicWeld RX (Resorb-X) - Resorbable Plating System (pins, screws, plates, meshes)
- Intended Use: Fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. Non-load bearing applications for maintaining relative position of bony fragments, bone grafts, or bone graft substitutes in reconstruction of craniofacial or mandibular areas.
- Proof Method: Substantial Equivalence to predicate devices.
- Predicate Devices:
- Basis for Equivalence:
- Chemical Composition: Identical to RESORB-X Resorbable Plating System (K011590) and Resorb-X SF (K051236).
- Implantation Method: Identical to RESORB-X Resorbable Plating System (K011590) and Resorb-X SF (K051236).
- Expanded Indications: This submission expanded the indications for use to include non-load bearing applications in the mandible, which was deemed substantially equivalent to the predicates.
In this context, the "acceptance criteria" are implied to be the regulatory requirements for showing substantial equivalence, and the "study" is the comparison made to predicate devices within the 510(k) submission.
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KO80862
:
kıs martın LP.
:
JUL 2 1 2008
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: | Tom FaucettRA/QA Supervisor | ||
| Date of Summary: | 18 March 2008 | ||
| Device Name: | SonicWeld RX (Resorb-X) | ||
| Trade Name: | SonicWeld RX (Resorb-X) | ||
| Common Name: | Bone Plate | ||
| ClassificationName and Number: | Bone Plate (872.4760) | ||
| Regulatory Class: | II | ||
| Predicate Devices: | Resorb-X Resorbable Plating System(K011590)Resorb-X SF (K051236)Synthes (USA) Rapid Resorbable FixationSystem (K062789) | ||
| Intended Use: | The KLS Martin SonicWeld RX (Resorb-X) isintended for use in fracture repair andreconstructive procedures of the craniofacialskeleton in pediatric and adult populations. Inaddition, resorbable meshes, plates, screwsand pins may be used in non-load bearingapplications for maintaining the relativeposition of, and/or containing, bony fragmentsbone grafts (autograft or allograft), or bonegraft substitutes in reconstruction of thecraniofacial or mandibular areas. |
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The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation. The KLS Martin SonicWeld RX (Resorb-X) is not intended for areas with active or latent infection or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not intended for use in the spine.
The SonicWeld Rx pins are designed only to be inserted with the SonicWeld Rx Sonotrode device.
The SonicWeld RX (Resorb-X) is identical to RESORB-X® SF (K051236) which consists of RESORB-X® Pins made of Poly (D, L) -Lactide-Acid (PDLLA) of various diameters and lengths that are implanted utilizing ultrasonic force generated by an ultrasonic unit that causes a phase transition in the pin, allowing the pin to adapt to the previously drilled pilot hole in the surgical site and utilize the micro undercuts of the bone for retention. The RESORB-X® SF pins are designed to be used in conjunction with RESORB-X® Resorbable Plating System plates (K011590).
Technological Characteristics:
Similarities to Predicate
The SonicWeld RX (Resorb-X) is identical to RESORB-X Resorbable Plating System (K011590) Resorb-X SF (K051236) in chemical composition.
The SonicWeld RX (Resorb-X) are the identical pins, screws and plates as the RESORB-X Resorbable Plating System (K011590) and Resorb-X SF (K051236) and are implanted in the identical manner.
Device Description:
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Differences to Predicate
This submission expands the indications for use to include use in non-load bearing applications in the mandible.
Substantial Equivalence:
The SonicWeld RX (Resorb-X)is substantially equivalent in intended use to the RESORB-X Resorbable Plating System (K011590), Resorb-X SF (K051236) and the Synthes (USA) Rapid Resorbable Fixation System (K062789)
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tom Faucett Senior Regulatory Affairs/ Quality Assurance Specialist KLS Martin L.P. 11239 St. Johns Industrial Parkway South Jacksonville Florida 32246
JUL 2 1 2008
Re: K080862
Trade/Device Name: SonicWeld RX (Resorb-X) Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: June 17, 2008 Received: June 18, 2008
Dear Mr. Faucett:
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. 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 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.
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Page 2 - Mr. Faucett
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a chassification 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runore
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
K080862 510(k) Number (if known):
SonicWeld RX (Resorb-X) Device Name:
Indications For Use: The KLS Martin SonicWeld RX (Resorb-X) is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, plates, screws and pins may be used in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of the craniofacial or mandibular areas. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation. The KLS Martin SonicWeld RX (Resorb-X) is not intended for areas with active or latent infection or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not intended for use in the spine.
The SonicWeld Rx pins are designed only to be inserted with the SonicWeld Rx Sonotrode device.
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 TF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Sue Kummer
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090562
Page 1 of
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.