(130 days)
The RapidFlap™ LS Cranial Flap Fixation System is indicated for use in rigid fixation of a craniotomy in adult and pediatric populations.
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.
This 510(k) summary (K130309) for the RapidFlap™ LS Cranial Fixation Flap System indicates that no clinical or non-clinical studies were performed to prove the device meets acceptance criteria.
The submission establishes substantial equivalence based on a comparison to predicate devices in terms of design, material, sterilization, and intended use, rather than through performance testing. The purpose of the submission was specifically to extend the indications for use to include adult populations, aligning it with predicate devices.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from this document as such studies were not conducted or reported in this 510(k).
Here's the relevant information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. Substantial equivalence was claimed solely based on comparison to predicate devices, not on specific performance criteria met through testing.
2. Sample size used for the test set and the data provenance:
Not applicable. No test set or clinical study was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No test set or ground truth establishment by experts for performance evaluation was conducted.
4. Adjudication method for the test set:
Not applicable. No test set or adjudication process for performance evaluation was conducted.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a physical medical implant, not an AI or imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No ground truth for performance evaluation was established as performance studies were not conducted.
8. The sample size for the training set:
Not applicable. No training set for an algorithm was used as this is a physical medical device.
9. How the ground truth for the training set was established:
Not applicable. No training set for an algorithm was used.
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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.
| AesculapCranioFixAbosorbableDevice(K021408 &K040080) | Synthes RapidResorbableClamp(K041611) | LactoSorb®RapidFlap™System(K003281) | RapidFlap™ LSCranial FixationSystem(subject device) | |
|---|---|---|---|---|
| Material | Poly (L/DL-lactide) | 85:15 poly (L-lactide-co-glycolide) | Polylactic /polyglycolic acidcopolymer | Polylactic /polyglycolic acidcopolymer |
| Materialproperty | Resorbable | Resorbable | Resorbable | Resorbable |
| Indications forUse | Covering burrholes andfixation ofcranial boneflaps | Covering burrholes and fixationof cranial boneflaps in adult andpediatricpopulations | Pediatriccraniotomy flapfixation | Rigid fixation of acraniotomy inadult and pediatricpopulations |
| Use | Craniotomyprocedures | Craniotomyprocedures | Craniotomyprocedures | Craniotomyprocedures |
| Sterility | Sterile | Sterile | Sterile | Sterile |
| Components | l 1mm, 16mm &20mm clamps | 18mm Clamp | 14mm Clamp | 14mm Clamp |
| Componentdescription | Two disksconnected by aratcheting shaft | Two disksconnected by atensionedratcheting shaft | Inner and outerplates (eachconsisting of acircular disk witha threaded hole)connected by athreaded centralpost | Inner and outerplates (eachconsisting of acircular disk with athreaded hole)connected by athreaded centralpost |
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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
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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
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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
Page 1 of 1
§ 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).