(87 days)
Not Found
No
The 510(k) summary describes mechanical modifications to surgical blades and burrs and does not mention any AI or ML components or functionalities.
No
The device is described as an accessory to fluid management systems used in arthroscopic surgery for cutting, burring, shaving, and abrading bone and tissue. Its function is primarily mechanical in assisting surgical procedures rather than directly treating a medical condition or disease.
No
The device is described as an accessory for arthroscopic surgery, specifically for cutting and abrading bone and tissue. Its intended use is surgical intervention, not diagnostic evaluation or detection of a disease or condition.
No
The device description explicitly states it consists of physical components like stainless steel tubes, plastic hubs, and sharp edges for cutting, 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 clearly states that the FMS Blades and Burrs are "intended to provide controlled cutting, burring, shaving and abrading of bone and tissue for use in arthroscopic surgery." This describes a surgical tool used directly on a patient's body during a procedure.
- Device Description: The description details the physical components and how they function to cut and abrade tissue. It does not mention any interaction with biological samples (like blood, urine, or tissue samples) outside of the body for diagnostic purposes.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing information about a patient's health status, disease, or condition.
- Using reagents or assays.
In summary, the FMS Blades and Burrs are surgical instruments used in vivo (within the living body) during arthroscopic procedures, not devices used in vitro (outside the living body) for diagnostic testing.
N/A
Intended Use / Indications for Use
The FMS Blades and Burrs are an accessory to the FMS Fluid Management Systems. FMS Blades and Burrs are intended to provide controlled cutting, burring, shaving and abrading of bone and tissue for use in arthroscopic surgery.
Product codes
HRX
Device Description
The purpose of this 510(k) Notification is to outline modifications made to the currently marketed FMS Blades and Burrs. The changes being made to the proposed devices are to enhance performance and include modifications including: material changes, modified inner and outer blade window profiles, and modified inner and outer burr tip geometry.
FMS Shaver Blades and Burrs are used with the FMSTM Tornado or Micro Hand pieces which are accessories to the and Fluid Management Systems. They consist of stainless steel outer tube and a rotating inner tube connected to an inner and outer plastic hubs. Distal tips of the tubes contain sharp edges to facilitate the cutting.
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)
Verification activities such as Blade Tissue Cutting, Burr Bone Cutting, Blade Shed Testing and Burr Shed Testing were performed on the proposed and predicate devices.
Results of performance and safety testing have demonstrated that the modified devices are substantially equivalent to the predicate devices.
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
Not Found
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
| K131191 | JUL 22 | ||
|---|---|---|---|
| 510(k) SUMMARY | |||
| Submitter's Name and | |||
| Address | Susan Kagan | ||
| Project Manager, Regulatory Affairs | |||
| DePuy Mitek, Inc. | |||
| a Johnson & Johnson company | |||
| 325 Paramount Drive | |||
| Raynham, MA 02767 | Telephone: 508-880-8097 | ||
| Facsimile: 508-977-6911 | |||
| e-mail: skagan@its.jnj.com | |||
| Date Prepared: April 25, 2013 | |||
| Name of Medical Device | Proprietary Name: | ||
| Common Name: | FMS Shaver Blades and Burrs | ||
| Blades and Burrs | |||
| Substantial Equivalence | Blades and Burrs for FMS Fluid Management System Shavers are | ||
| substantially equivalent to the Blades and Burrs covered in the following | |||
| cleared systems: | |||
| • K954465 - FMS DUO pump and shaver system | |||
| • K041824 - NeXtraTM arthroscopic pump and shaver system | |||
| Device Classification | Classification Name: | ||
| Arthroscope | |||
| Classification Number: | |||
| 21 CFR 888.1100 Class II | |||
| Product Code: | |||
| HRX | |||
| Device Description | The purpose of this 510(k) Notification is to outline modifications made to | ||
| the currently marketed FMS Blades and Burrs. The changes being made to | |||
| the proposed devices are to enhance performance and include modifications | |||
| including: material changes, modified inner and outer blade window profiles, | |||
| and modified inner and outer burr tip geometry. | |||
| FMS Shaver Blades and Burrs are used with the FMSTM Tornado or Micro | |||
| Hand pieces which are accessories to the and Fluid Management Systems. | |||
| They consist of stainless steel outer tube and a rotating inner tube connected | |||
| to an inner and outer plastic hubs. Distal tips of the tubes contain sharp edges | |||
| to facilitate the cutting. | |||
| Indications for Use | The FMS Blades and Burrs are an accessory to the FMS Fluid Management | ||
| Systems. FMS Blades and Burrs are intended to provide controlled cutting, | |||
| burring, shaving and abrading of bone and tissue for use in arthroscopic |
FMS Blades and Burrs
Traditional 510(k)
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1
surgery.
| Nonclinical Testing | Verification activities such as Blade Tissue Cutting, Burr Bone Cutting, Blade Shed Testing and Burr Shed Testing were performed on the proposed and predicate devices. |
|---|---|
| Safety and Performance | Results of performance and safety testing have demonstrated that the modified devices are substantially equivalent to the predicate devices. |
| Based on the indications for use, technological characteristics, and comparison to predicate devices, the proposed Blades and Burrs have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act. |
FMS Blades and Burrs
Traditional 510(k)
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· :
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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
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
DePuy Mitek Incorporated a Johnson & Johnson Company % Ms. Susan Kagan Project Manager, Regulatory Affairs 325 Paramount Drive Raynham. Massachusetts 02767
ymann, IVR33
Re: K131191
Trade/Device Name: Blades and Burrs for FMS Shavers Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Codc: HRX Dated: April 25, 2013 Received: April 26, 2013
Dear Ms. Kagan:
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 docs not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not mislcading.
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 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
July 22, 2013
3
Page 2 - Ms. Susan Kagan
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.
If 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,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE STATEMENT
INDICATIONS FOR USE
510(k) Number (if known): K131191
Device Name: Blades and Burrs for FMS Shavers
Indications for Use: The FMS Blades and Burrs are an accessory to the FMS Fluid Management Systems. FMS Blades and Burrs are intended to provide controlled cutting, burring, shaving and abrading of bone and tissue for use in arthroscopic surgery.
V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page I of 1
Joshua C. Nipper -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131191