(74 days)
Not Found
Not Found
No
The device description focuses on the material properties and physical manipulation of the panels, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is used for reconstructive and trauma procedures of the midface or craniofacial skeleton, which are interventions aimed at treating or improving a patient's condition.
No
Explanation: The device description clearly states that the LactoSorb® Panels are used for surgical procedures like trauma and reconstruction, where they are shaped and affixed to bone. This is a therapeutic or surgical device, not one for diagnosing medical conditions.
No
The device description clearly describes physical panels made of bioresorbable polymers, a heat pack for heating the panels, and screws/rivets for fixation. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The LactoSorb® Panels are described as sheets of bioresorbable material used for surgical procedures to fix fractures and reconstruct bones in the midface and craniofacial skeleton. They are physically implanted into the body.
- Intended Use: The intended use is for surgical procedures involving trauma and reconstruction of the midface and craniofacial skeleton. This is a direct surgical intervention, not a diagnostic test performed on a specimen.
The device is a surgical implant used for structural support and fixation within the body, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
A. General Indication: trauma procedures of the midface or craniofacial skeleton
Specific Indications:
- comminuted fractures of the naso-ethmoidal infraobital areas
- comminuted fractures of the frontal sinus wall
- pediatric midface or craniofacial trauma
- orbital floor fractures
- trauma of the craniofacial skeleton ficluding: frontal; parietal, temporal, sphenoid, and occipital bones
B. General Indication: reconstructive procedures of the midface or craniofacial skeleton
Specific Indications:
- Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
- tumor reconstruction in midface or craniofacial procedures
- bone graft procedures in the midface or craniofacial skeleton
- pediatric reconstructive procedures
- reconstructive procedures of the craniofacial skeleton including: frontal, parietal,temporal, sphenoid, and occipital bones
- craniotomy flap fixation
Product codes
HRS
Device Description
The LactoSorb® Panels consist of sheets of LactoSorb® available in various sizes. The panels can be heated to malleable state and cut/shaped to conform to the bony anatomy. Heating is done using a sterile LactoSorb® Heat Pack.
At the time of surgery, drill holes can be placed as needed to accept LactoSorb® screws and rivets. These devices are not for use in the mandible or other load bearing indications.
The LactoSorb® Panels are made of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. syncheers polycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. The LactoSorb® material has been found to be biocompatible in both soft tissue and bone tissue. The material retains its strength for at least 8 weeks and completely resorb by 9-15 months.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
midface or craniofacial skeleton, naso-ethmoidal infraorbital, frontal sinus wall, orbital floor, frontal, parietal, temporal, sphenoid, and occipital bones.
Indicated Patient Age Range
Infant, pediatric
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)
Biomechanical testing has proven that the LactoSorb® Panels will be as effective as the predicate devices in midface and craniofacial procedures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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.
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Image /page/0/Picture/1 description: The image shows a black and white drawing of a group of islands. The islands are scattered across the image, with some appearing larger than others. The islands are surrounded by a white background, which could represent the ocean.
SUMMARY OF SAFETY AND EFFECTIVENESS
The LactoSorb® Panels consist of sheets of LactoSorb® available in various sizes. The panels can be heated to malleable state and cut/shaped to conform to the bony Heating is done using a sterile LactoSorb® Heat anatomy. Pack.
The LactoSorb® Panels are used as fixation devices in the following procedures.
- A. General Indication: trauma procedures of the midface or craniofacial skeleton Specific Indications:
-
- Comminuted fractures of the naso-ethmoidal infraorbital areas
-
- Comminuted fractures of the frontal sinus wall
-
- Pediatric midface or craniofacial trauma
-
- Orbital floor fractures
- Trauma of the craniofacial skeleton including: 5. frontal, parietal, temporal, sphenoid, and occipital bones
-
B. General Indication: reconstructive procedures of the midface or craniofacial skeleton Specific Indications:
-
- Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma etc.)
-
- Tumor reconstruction in midface or craniofacial procedures
-
- Bone graft procedures in the midface or craniofacial skeleton
-
- Pediatric reconstructive procedures
-
- Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
-
- Craniotomy flap fixation
At the time of surgery, drill holes can be placed as needed to accept LactoSorb® screws and rivets. These devices are not for use in the mandible or other load bearing indications.
The LactoSorb® Panels are made of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a
Image /page/0/Picture/22 description: The image shows the number 0004 in a bold, black font. The numbers are closely spaced together and are easily readable. The background is white, which provides a strong contrast to the black numbers. There are some small black marks to the right of the number 4.
1
synthetic polyester derived from lactic and glycolic acids. syncheers polycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. The LactoSorb® material has been found to be biocompatible in both soft tissue and bone tissue. The material retains its strength for at least 8 weeks and completely resorbs by 9-15 months.
The LactoSorb® Panels are used in a similar manner as the LactoSorb® mesh in the LactoSorb® Trauma Plating System as well as thin metal meshes and a variety of other devices. Biomechanical testing has proven that the LactoSorb® Panels will be as effective as the predicate devices in midface and craniofacial procedures.
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Image /page/2/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 a stylized image of an eagle with three stripes extending from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 30 1998
Ms. Mary Verstynen · Clinical Research Manager Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
K974309 Re: LactoSorb® Panels Regulatory Class: II Product Code: HRS Dated: November 13, 1997 Received: November 17, 1997
Dear Ms. Verstynen:
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 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 (Premarket Approval), 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 895. ದ 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. Please note: concerning your device in the Federal Register. 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 regulations.
3
Page 2 - Ms. Mary Verstynen
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
premarket notification" (21 CFR 807.97). Other general 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
4
| Page | ___ |
|---|---|
| of | ___ |
510(k) Number (if known): K974309
Oevice Name: LactoSorbR Panels
Indications For Use:
-
A. General Indication: trauma procedures of the midface or craniofacial skeleton
Specific Indications: -
- comminuted fractures of the naso-ethmoidal infraobital areas
-
- comminuted fractures of the frontal sinus wall
-
- pediatric midface or craniofacial trauma
-
- orbital floor fractures
-
- trauma of the craniofacial skeleton ficluding: frontal; parietal, temporal, sphenoid, and occipital bones
B. General Indication: reconstructive procedures of the midface or craniofacial skeleton Specific Indications:
-
- Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
-
- tumor reconstruction in midface or craniofacial procedures
-
- bone graft procedures in the midface or craniofacial skeleton
-
- pediatric reconstructive procedures
-
- reconstructive procedures of the craniofacial skeleton including: frontal, parietal,temporal, sphenoid, and occipital bones
-
- craniotomy flap fixation
(PLEASE OO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K974309 |
| Prescription Use | |
| (Per 21 CFR 801.1091 | X |
| OR | Over-The-Counter Use |
| (Optional Format 1-2-96) |