(130 days)
No
The device description and intended use focus on mechanical fixation and a heating tool, with no mention of AI/ML terms or functions.
No.
The device is indicated for rigid fixation of a craniotomy, which is a structural support function and not a therapeutic one. It does not treat a disease or condition.
No
Explanation: The device is described as a "Cranial Flap Fixation System" used for rigid fixation of a craniotomy, which is a surgical procedure for holding bone flaps in place, not for diagnosing conditions.
No
The device description clearly outlines physical components (inner plate, outer plate, central post, heat/contouring pen) made of materials like polylactic/polyglycolic acid copolymer and powered by batteries. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The RapidFlap™ LS Cranial Flap Fixation System is a surgical implant used for the physical fixation of a bone flap during a craniotomy. It is a mechanical device that interacts directly with the patient's bone.
- Lack of Diagnostic Testing: The description does not mention any analysis of biological samples or the provision of diagnostic information. Its purpose is purely structural and mechanical.
Therefore, based on the provided information, the RapidFlap™ LS Cranial Flap Fixation System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RapidFlap™ LS Cranial Flap Fixation System is indicated for use in rigid fixation of a craniotomy in adult and pediatric populations.
Product codes
GXR
Device Description
The RapidFlap™ LS Cranial Flap Fixation System is comprised of three parts, an inner plate, an outer plate and a central post. The inner plate consists of a circular disk through which the post is centrally extruded outwardly. The outer plate consists of a circular disk which a threaded hole to accept the post. The devices are assembled by hand to force the plates together capturing the bone. When applied, the plates tightly grip the bone flap, and provide rigid attachment and coplanar alignment to the surrounding bone. The RapidFlap™ LS System is made from Polylactic / polyglycolic acid copolymer.
The LactoSorb® Heat /Contouring Pen is a disposable alkaline-battery powered device. Two tips are provided with the body or handle of the device. These tips can use the same handle to perform slightly different functions. The long wire tip is used to cut the LactoSorb® plates and the flat surfaced tip is used to smooth the edges of the plates. The device is supplied sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniotomy (cranial)
Indicated Patient Age Range
adult and pediatric populations
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)
Substantial equivalence was not based on nonclinical or clinical data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K003281, K021408, K040080, K041611
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5250 Burr hole cover.
(a)
Identification. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.(b)
Classification. Class II (performance standards).
0
K130309
510(k) Summary
June 11, 2013
Contact:
Biomet Microfixation 1520 Tradeport Drive Jacksonville, FL 32218 Sheryl Malmberg, Global R/A Specialist Telephone: 904-741-9465 Fax: 904-741-9425
Common of Usual Name: Cover, Burr hole
Classification Name: 882.5250 - Burr hole cover
Device Classification: Class II
Device Product Code: GXR
Device Name: RapidFlap™ LS Cranial Fixation Flap System
Indications for Use / Intended Use: The RapidFlap™ LS Cranial Flap Fixation System is indicated for use in rigid fixation of a craniotomy in adult and pediatric populations.
Contraindications: 1. Active infection: 2. Patient conditions including blood supply limitations, insufficient quantity of bone stock or latent infection; 3. DO NOT USE in patients with a decompression flap.
Description: The RapidFlap™ LS Cranial Flap Fixation System is comprised of three parts, an inner plate, an outer plate and a central post. The inner plate consists of a circular disk through which the post is centrally extruded outwardly. The outer plate consists of a circular disk which a threaded hole to accept the post. The devices are assembled by hand to force the plates together capturing the bone. When applied, the plates tightly grip the bone flap, and provide rigid attachment and coplanar alignment to the surrounding bone. The RapidFlap™ LS System is made from Polylactic / polyglycolic acid copolymer.
The LactoSorb® Heat /Contouring Pen is a disposable alkaline-battery powered device. Two tips are provided with the body or handle of the device. These tips can use the same handle to perform slightly different functions. The long wire tip is used to cut the LactoSorb® plates and the flat surfaced tip is used to smooth the edges of the plates. The device is supplied sterile.
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Sterility Information: The LactoSorb® implants are sterilized by exposure to Ethylene Oxide (ETO) Gas.
Substantial Equivalence: The RapidFlap™ LS Cranial Fixation System is substantially equivalent to the LactoSorb® RapidFlap™ System (K003281), Aesculap CranioFix Abosorbable Device (K021408 & K040080) and the Synthes Rapid Resorbable Clamp (K041611). Substantial equivalence was not based on nonclinical or clinical data. The following comparison table shows that all devices are similar in design, material, sterilization and intended use. The purpose of this submission is only to include adult populations in the current indications for use, which is consistent with predicate devices shown below.
| | Aesculap
CranioFix
Abosorbable
Device
(K021408 &
K040080) | Synthes Rapid
Resorbable
Clamp
(K041611) | LactoSorb®
RapidFlap™
System
(K003281) | RapidFlap™ LS
Cranial Fixation
System
(subject device) |
|--------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Poly (L/DL-
lactide) | 85:15 poly (L-
lactide-co-
glycolide) | Polylactic /
polyglycolic acid
copolymer | Polylactic /
polyglycolic acid
copolymer |
| Material
property | Resorbable | Resorbable | Resorbable | Resorbable |
| Indications for
Use | Covering burr
holes and
fixation of
cranial bone
flaps | Covering burr
holes and fixation
of cranial bone
flaps in adult and
pediatric
populations | Pediatric
craniotomy flap
fixation | Rigid fixation of a
craniotomy in
adult and pediatric
populations |
| Use | Craniotomy
procedures | Craniotomy
procedures | Craniotomy
procedures | Craniotomy
procedures |
| Sterility | Sterile | Sterile | Sterile | Sterile |
| Components | l 1mm, 16mm &
20mm clamps | 18mm Clamp | 14mm Clamp | 14mm Clamp |
| Component
description | Two disks
connected by a
ratcheting shaft | Two disks
connected by a
tensioned
ratcheting shaft | Inner and outer
plates (each
consisting of a
circular disk with
a threaded hole)
connected by a
threaded central
post | Inner and outer
plates (each
consisting of a
circular disk with a
threaded hole)
connected by a
threaded central
post |
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2013
Biomet Microfixation % Ms. Christine Scifert Managing Partner Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, TN 38133
Re: K130309
Trade/Device Name: RapidFlap™ LS Resorbable Cranial Flap Fixation System Regulation Number: 21 CFR 882.5250 Regulation Name: Burr Hole Cover Regulatory Class: Class II Product Code: GXR Dated: March 20, 2013 Received: March 21, 2013
Dear Ms. Scifert:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Ms. Christine Scifert
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address_______________________________________________________________________________________________________ http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Victor Krauthamer -S
Victor Krauthamer, Ph.D. Acting Division Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K130309
Device Name: RapidFlap™ LS Resorbable Cranial Flap Fixation System
Indications For Use:
The RapidFlap™ LS Cranial Flap Fixation System is indicated for use in rigid fixation of a craniotomy in adult and pediatric populations.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Victor Krautham 2013.06.14 17:46:
Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K130309
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