(50 days)
No
The 510(k) summary describes a mechanical cranial clamp for re-attaching a bone flap and does not mention any AI or ML components or functionalities.
No
The device is a cranial clamp used for the re-attachment of bone flaps, which is a structural support device rather than one that treats or diagnoses a disease/condition.
No
The device is indicated for the re-attachment of the bone flap after a craniotomy, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components (threaded stem, upper and lower plates) made of specific materials (CP Titanium, Titanium 6A1 4V alloy) and indicates sterility, all of which are characteristics of a hardware medical device, not a software-only one.
Based on the provided information, the Spin Down RapidFlap is not an IVD (In Vitro Diagnostic) device.
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 implantable device made of titanium alloys, designed for mechanical attachment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. The Spin Down RapidFlap is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Spin Down RapidFlap is indicated for the re-attachment of the bone flap after a craniotomy.
Product codes
GXN
Device Description
| Spin Down RapidFlapmodification | K971252 SevrainCranial Clamp | K991029 RapidFlapCranial Clamp | |
|---|---|---|---|
| Attachment ofupper and lowerplates | Threaded stemattachment betweenthe upper and lowerplates | Threaded stemattachment betweenupper and lower plates | Grooved postconnection betweenthe upper and lowerplates. |
| Material | CP Titanium andTitanium 6A1 4V alloy | CP Titanium, grade 2 | Titanium 6A1 4V alloy |
| Sterility | Sterile | Non-Sterile | Sterile |
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)
Reference Device(s)
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
MAY 21 2003
K03-1034
page 1 of 1
Summary of Safety and Effectiveness
Device Modification Name: Spin down rapidflap
| Name of previously cleared 510(k): | Sevrain Cranial Clamp SCC100 - 510(k) K971252 |
|---|---|
| RapidFlap Cranial Clamp - 51k(k) K9910229 |
Classification Name: Plate, Cranioplasty, Preformed, Non-Alterable
Product Code and Reference: 84 GXN (21 CFR - 882.5330)
Intended use: Spin Down RapidFlap is indicated for the re-attachment of the bone flap after a craniotomy.
Device Modification Description:
| | Spin Down RapidFlap
modification | K971252 Sevrain
Cranial Clamp | K991029 RapidFlap
Cranial Clamp |
|--------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------|----------------------------------------------------------------------|
| Attachment of
upper and lower
plates | Threaded stem
attachment between
the upper and lower
plates | Threaded stem
attachment between
upper and lower plates | Grooved post
connection between
the upper and lower
plates. |
| Material | CP Titanium and
Titanium 6A1 4V alloy | CP Titanium, grade 2 | Titanium 6A1 4V alloy |
| Sterility | Sterile | Non-Sterile | Sterile |
Potential Risks:
The potential risks associated with the Spin Down RapidFlap are the same as with the Sevrain Cranial Clamp (K971252), SCC-100 and RapidFlap Cranial Clamp (K991029). The following are contraindicated in the package insert:
-
- Patients with a decompression flap.
-
- Active infection or latent infection.
-
- Patient with insufficient quantity or quality of bone.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle with three curved lines representing its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged around the circumference of the circle.
Public Health Service
MAY 21 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kim Reed Senior Regulatory Specialist Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, Florida 32218-2480
Re: K031034
Trade/Device Name: Spin Down RapidFlap Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: II Product Code: GXN Dated: March 31, 2003 Received: April 1, 2003
Dear Ms. Reed:
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 misbrarding 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 set 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.
2
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): (03-103
Spin down rapidflap Device Name:
Indications For Use:
Spin Down RapidFlap is indicated for the re-attachment of the bone flap after a craniotomy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark A. Milker
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K031034
Prescription Use (Per 21 CFR 801.109) OR
510(k) Number -
Over-The-Counter Use __
(Optional Format 1-2-96)
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