(188 days)
No
The summary describes a system of physical implants and surgical tools, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is intended for surgical procedures to repair sternal deformities and stabilize fractures, fusions, and osteotomies, which are therapeutic interventions.
No
The device descriptions and intended uses clearly state that these are implant systems designed for surgical repair, stabilization, and fixation of sternal and rib deformities/fractures. They are not described as tools for diagnosing medical conditions.
No
The device description explicitly states it consists of physical components like bars, stabilizers, clips, and pins, which are hardware implants.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical procedures to repair Pectus Excavatum, other sternal deformities, and to stabilize and provide fixation for fractures, fusions, osteotomies of the ribs, and reconstructions of the chest wall and sternum. This describes a surgical implant used in vivo (within the body) for structural support and repair.
- Device Description: The description details physical implants (bars, stabilizers, clips) designed to be surgically placed within the body.
- 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 treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / 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.
Product codes
HRS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ribs, chest wall and sternum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical procedures
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 888.3030 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.
0
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 |
1
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.
2
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
3
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
4
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
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