(45 days)
Not Found
Not Found
No
The device description is purely mechanical and there is no mention of AI or ML in the summary.
Yes
The device is described as a stainless steel bar intended for use in surgical procedures to repair Pectus Excavation and other sternal deformities, which are conditions requiring medical treatment or correction, making the device therapeutic.
No
The description explicitly states the device is intended for use in surgical procedures to repair sternal deformities, indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly states it is a "stainless steel bar," which is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures to repair sternal deformities. This is a surgical implant used in vivo (within the body).
- Device Description: The device is a physical bar implanted during surgery.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
This device clearly falls under the category of a surgical implant or device used directly on the patient during a procedure, not for testing samples in a lab.
N/A
# Intended Use / Indications for Use
This device is intended for use in surgical procedures to repair Pectus Excavation and other sternal deformities.
# Product codes
HRS
# Device Description
A stainless steel bar, variable length from 7 to 14 inches, and 0.50 inches wide, with two holes and notches on both ends for sutures to secure the bar to the lateral chest wall (a drawing is included in Attachment I.) . The bar is shaped by the surgeon prior to insertion.
# Mentions image processing
Not Found
# Mentions AI, DNN, or ML
Not Found
# Input Imaging Modality
Not Found
# Anatomical Site
Not Found
# 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)
Not Found
# Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
# Predicate Device(s)
The Adkins Strut, manufactured by American V. Mueller, The Strib, manufactured by the Medic-Made Company
# Reference Device(s)
Not Found
# Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K972420 AU
Summary of Safety and Effectiveness
Device Name: Lorenz Pectus Support Bar
Classification Name and Reference: Plate, Fixation, Bone 87 HRS (CFR 888.3030)
Device Description: A stainless steel bar, variable length from 7 to 14 inches, and 0.50 inches wide, with two holes and notches on both ends for sutures to secure the bar to the lateral chest wall (a drawing is included in Attachment I.) . The bar is shaped by the surgeon prior to insertion.
Potential Risks:
The potential risks associated with the support bar are the same as with any long-term, metallic implant These include but are not limited to the following;
- Inadequate bone quality
- Malpositioning of implant .
- Infection .
- o Nerve Injury
- Bending/fracture of implant .
Substantially Equivalent Devices:
- The Adkins Strut, manufactured by American V. Mueller ●
- The Strib, manufactured by the Medic-Made Company .
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. The text is in all caps and evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Diana Preston Requlatory Affairs Specialist Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville. Florida 32218-2480
AUG 1 1 1997
Re : K972420 Lorenz Pectus Support Bar Requlatory Class: II Product Code: HRS Dated: June 23, 1997 Received: June 27, 1997
Dear Ms. Preston:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
2
Page 2 - Ms. Diana Preston
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regalacion chororous ( information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
3
Page 1 of l
510(k) Number (if known): K972420
Device Name: Lorenz Pectus Support Bar
Indications For Use: This device is intended for use in surgical procedures to repair Pectus Excavation and other sternal deformities.
(PLEASE DO NOT WRITE BELOG THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED!
Concurrence of CDRH, Office of Device Evaluation (ODE)
Acsella
(Division Sign-Off) Division of General Restorative Lie nees 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use_X (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)