(25 days)
Not Found
No
The summary describes a mechanical device for bone flap re-attachment and does not mention any software, algorithms, or AI/ML components.
No
The device is used for re-attachment of a bone flap after craniotomy, which is a structural repair rather than a therapeutic treatment.
No
Explanation: The device is a RapidFlap, which is indicated for the re-attachment of the bone flap after a craniotomy. This is a surgical device used for structural support, not for diagnosing a condition.
No
The device description explicitly details physical components (upper and lower plates, grooved post connection) and material (titanium alloy), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "re-attachment of the bone flap after a craniotomy." This is a surgical procedure performed directly on a patient's body.
- Device Description: The description details a physical implant made of titanium, designed for surgical use.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used for structural support during a procedure.
N/A
Intended Use / Indications for Use
RapidFlap is indicated for the re-attachment of the bone flap after a craniotomy.
Product codes (comma separated list FDA assigned to the subject device)
84 GXN
Device Description
The modification to the SCC-100 device are as follows:
1. Attachment of upper and lower plates
- SCC-100 identified a threaded stem attachment between the upper and lower plates .
- · Modified RapidFlap device has a grooved post connection between the upper and lower plates.
2. The material
- SCC-100 identifies commercially pure titanium, grade 2 material ●
- Modified RapidFlap device is manufactured from titanium 6 Al 4 V alloy. .
3. Sterility
- SCC-100 device is nonsterile .
- Modified RapidFlap device will be marketed sterile (details described under . sterility information).
4. Drawings for necessary instrumentation changes for application of modified device is included in Attachment I.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranial (bone flap)
Indicated Patient Age Range
The RapidFlap device has not been designed for use in pediatric neurosurgery. The effect of skull growth on retention is unknown.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).
0
4/23/99
Summary of Safety and Effectiveness
Device Modification Name: RapidFlap Cranial Clamp
Name of previously cleared 510(k): Sevrain Cranial Clamp SCC100 - 510(k) K971252
Classification Name: Plate, Cranioplasty, Preformed, Non-Alterable
Product Code and Reference: 84 GXN (21 CFR - 882.5330)
Intended use: RapidFlap is indicated for the re-attachment of the bone flap after a craniotomy.
Device Modification Description: The modification to the SCC-100 device are as follows:
1. Attachment of upper and lower plates
- SCC-100 identified a threaded stem attachment between the upper and lower plates .
- · Modified RapidFlap device has a grooved post connection between the upper and lower plates.
-
- The material
- SCC-100 identifies commercially pure titanium, grade 2 material ●
- Modified RapidFlap device is manufactured from titanium 6 Al 4 V alloy. .
-
- Sterility
- SCC-100 device is nonsterile .
- Modified RapidFlap device will be marketed sterile (details described under . sterility information).
-
- Drawings for necessary instrumentation changes for application of modified device is included in Attachment I.
Potential Risks:
The potential risks associated with the RapidFlap are the same as with the Sevrain Cranial Clamp, SCC-100. The following are contraindicated in the package insert:
-
- Patients with a decompression flap.
-
- Active infection.
-
- Patient conditions including, blood supply limitation, insufficient quantity of bone, or latent infection.
-
- Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
-
- Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation.
-
- RapidFlap device has not been designed for use in pediatric neurosurgery. The effect of skull growth on retention is unknown.
-
- Not intended for use in patients likely to require reoperation. This device has not been demonstrated clinically to be removable after long term implantation.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized human figure or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 1999
Ms. Diana Preston Requlatory Affairs Specialist Walter Lorenz Surqical, Inc. 1520 Tradeport Drive Jacksonville, Florida 32218
Re: K991029 Trade Name: RapidFlap Cranial Clamp Requlatory Class: II Product Code: GXN March 26, 1999 Dated: March 29, 1999 Received:
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 reqistration, 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 requlation (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 action. In addition, FDA may publish further announcements 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 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
3
Page 1 of 1
510(k) Number (if known): unknown
RapidFlap Cranial Clamp Device Name:
RapidFlap is indicated for the re-attachment of the bone flap after a Indications For Use: craniotomy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Acoela
(Division S Division orative Devices 510(k) Nun
Prescription Use >> (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)