(188 days)
MedXpert's P.E.S. implant system is intended for use in surgical procedures to repair Pectus Excavatum and other sternal deformities.
MedXpert's STRATOS™ implant system is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and reconstructions of chest wall and sternum.
MedXpert's P.E.S. implant system is consisting out of straight bars which can be bended according to the individual anatomic needs of the patient and different stabilizer which can be attached to the bar and secured by the BarLock™ Pin.
MedXpert's STRATOS™ implant system is consisting out of Bar and Rip Clips; Rip Clips are combined by press fit with the bar and with the rips.
The provided text is a 510(k) summary for the MedXpert P.E.S. and STRATOS™ implant systems. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a specific study proving device performance against those criteria.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not available in this document. The document primarily serves to establish regulatory equivalence based on intended use and device description.
Here's a breakdown of what can be gleaned and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided document. The 510(k) summary does not define specific performance acceptance criteria or report on device performance against such criteria. It relies on demonstrating substantial equivalence to legally marketed predicate devices, implying that if it's equivalent, it meets the same performance standards (which are not explicitly detailed here).
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not available. This 510(k) relies on substantial equivalence. There is no mention of a "test set" in the context of clinical performance evaluation (e.g., using patient data). The evaluation appears to be based on comparison of design, materials, and intended use with existing devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable/Not available. As there is no "test set" in the sense of patient data requiring ground truth establishment, this information is not relevant to the content provided.
4. Adjudication Method for the Test Set
Not applicable/Not available. This document does not describe a study involving adjudication of a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC study was not done. The document makes no mention of any clinical comparative effectiveness study, especially one involving human readers and AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done. This device is a physical implant system, not a software algorithm that would have standalone performance measured.
7. The Type of Ground Truth Used
Not applicable/Not available. Without a study involving analysis of patient data or clinical outcomes against a "ground truth," this concept does not apply to the provided 510(k) summary. The "ground truth" in a 510(k) for substantial equivalence is often the performance and safety record of the predicate devices.
8. The Sample Size for the Training Set
Not applicable/Not available. This 510(k) is for a physical medical implant, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not available. This is not relevant for the type of device and regulatory submission presented.
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MEDXPERT
K073556
JUN 2 4 2008
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS IN ACCORDANCE WITH SMDA OF 1990
Date of Application: November 21, 2007
APPLICANT:
MedXpert GmbH Poststr. 55 D-79423 Heitersheim Germany Phone: +49 (7634) 506886 Fax: +49 (7634) 506887 Email: info@medxpert.com
1. Device Name
| Trade Name: | MedXpert P.E.S. (Pectus Excavatum System) |
|---|---|
| MedXpert STRATOS™ |
Pectus Excavatum System Common Name:
2. Classification
Our implant system can be classified according following device names and product codes:
| Device: | MedXpert STRATOS™MedXpert P.E.S. (Pectus Excavatum System) |
|---|---|
| Medical Specialty: | Part 878, General & Plastic Surgery |
| Product Code: | HRS |
| Regulation Number: | 888.3030 |
| Device Class: | 2 |
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P.E.S. & STRATOS™ 510(k) Application
MEDXPERT
Substantial Equivalence 3.
MedXpert's P.E.S & STRATOS™ implant systems are substantial equivalent to the Lorenz Pectus Support Bar (K972420), Lorenz Pectus Support Bar Stabilizer (K981789) and Lorenz Pectus Support Bar System (K061384) of Walter Lorenz Surgical, Inc., Acute Bone Screw (K061206) of Acute Innovations LLC, and MacroPore OS Reconstruction System (K024169) of MacroPore Biosurgery, Inc.
Description of the Device 4.
MedXpert's P.E.S. implant system is consisting out of straight bars which can be bended according to the individual anatomic needs of the patient and different stabilizer which can be attached to the bar and secured by the BarLock™ Pin.
MedXpert's STRATOS™ implant system is consisting out of Bar and Rip Clips; Rip Clips are combined by press fit with the bar and with the rips.
Intended Use 5.
MedXpert's P.E.S. implant system is intended for use in surgical procedures to repair Pectus Excavatum and other sternal deformities.
MedXpert's STRATOS™ implant system is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and reconstructions of chest wall and sternum.
Conclusion 6.
Based on the available 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that MedXpert's P.E.S & STRATOS™ implant systems are substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MedXpert GmbH % Medagent GmbH & Co. KG Mr. Franz Menean Griesweg 47 Muhlheim, Baden-Wurttemberg Germany 78570
JUN 2 4 2008
K073556 Trade/Device Name: MedXpert P.E.S. (Pectus Excavatum System), MedXpert STRATOS Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: May 30, 2008 Received: June 11, 2008
Dear Mr. Menean:
Re:
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.
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 sct
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Page 2 - Mr. Franz Menean
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 classification 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) 276-0120. 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 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Milliman
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K073556(pg 1/1)
Indications for Use
510(k) Number: K073556
Device Name: MedXpert P.E.S. (Pectus Excavatum System) Implant System MedXpert STRATOS™ Implant System
Indications for Use:
MedXpert's P.E.S. implant system is intended for use in surgical procedures to repair Pectus Excavatum and other sternal deformities.
MedXpert's STRATOS™ implant system is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and reconstructions of chest wall and sternum.
Prescription Use _ YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ NO (21 SFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cenbare Buem
Division of General, Restorative, and Neurological Devices
510(k) Number K073556
Page 1 of 1
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.