(73 days)
Not Found
No
The description focuses on mechanical cutting and fluid management, with no mention of AI/ML terms or functionalities.
Yes
The device is intended for "controlled cutting, burring, shaving and abrading of bone and tissue for use in arthroscopic surgery," which are clinical procedures performed to treat medical conditions.
No
The device, FMS Blades and Burrs, is described as an accessory to Fluid Management Systems, intended for cutting, burring, shaving, and abrading bone and tissue during arthroscopic surgery. This describes a surgical tool for treatment, not a device used to identify or diagnose a condition.
No
The device description clearly states it consists of physical components like stainless steel tubes and plastic hubs with 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 is "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 the patient's body during a procedure.
- Device Description: The description details a mechanical device with blades and tubes for cutting tissue. This is consistent with a surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
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 (comma separated list FDA assigned to the subject device)
HRX
Device Description
OMNICUT Blades are used with FMS™ Handpieces and Fluid Management Systems during arthroscopic surgery. OMNICUT Blades 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)
Design verification activities, such as soft tissue and bone tissue removal, as well as blade particulate generation testing, were performed on OMNICUT blades and their predicate devices. While there are no required tests for arthroscopy blades, the following preclinical studies were submitted to demonstrate substantial equivalence: Blade soft tissue cutting comparison with K953695 predicate. Blade bone cutting comparison with K953695 predicate. Blade shed testing comparison with K953695 predicate. The OMNICUT blades passed all tests and showed equivalent performance.
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
§ 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
K130912 Page 1 of 2
・
510(k) SUMMARY
.
JUN 1 4 2013
・
.
| Submitter's
Name and
Address | DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Tatyana Korsunsky
Regulatory Affairs Specialist
DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA
Telephone: 508-828-3122
Facsimile: 508-977-6911
e-mail: tkorsuns@its.jnj.com |
| Name of
Medical Device | Proprietary Name: OMNICUT™ Resection Blade
Common Name: Blade |
| Substantial
Equivalence
Facility | The OMNICUT™ blades are substantially equivalent to:
K953695: Dyonics Disposable Arthroscopic Blades (Full Radius Bonecutter blade) K954465: FMS DUO® pump and shaver system (FMS blades) K041824: FMS NeXtra™ arthroscopic pump and shaver system (FMS blades) |
| Device
Classification | Classification Name: Arthroscope
Classification Number: 21 CFR 888.1100 Class II
Product Code: HRX |
| Device
Description | OMNICUT Blades are used with FMS™ Handpieces and Fluid Management Systems
during arthroscopic surgery. OMNICUT Blades 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 surgery. |
| Nonclinical
Testing | Design verification activities, such as soft tissue and bone tissue removal, as well as
blade particulate generation testing, were performed on OMNICUT blades and their
predicate devices. |
| Safety and
Performance | While there are no required tests for arthroscopy blades, the following
preclinical studies were submitted to demonstrate substantial equivalence:
Blade soft tissue cutting comparison with K953695 predicate. Blade bone cutting comparison with K953695 predicate. Blade shed testing comparison with K953695 predicate. The OMNICUT blades passed all tests and showed equivalent performance. |
1
Results of performance and safety testing have demonstrated that the proposed devices are suitable for their intended use. Based on the indications for use, technological characteristics, and comparison to predicate devices, the proposed OMNICUT Blades have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
Comparison to The proposed OMNICUT Blades have the same intended use and are similar in the predicate design and materials to the predicate Smith & Nephew's Full Radius Bonecutter devices blades (K953695) and Mitek's FMS blades (K954465/ K041824). However, the proposed OMNICUT blades have a modified cutting window configuration and are provided lubricated. The proposed OMNICUT device can cut both bone and soft tissue, similar to a predicate Smith & Nephew's Full Radius Bonecutter blade.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 14, 2013
DePuy Mitek % Ms. Tatyana Korsunsky Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767
Re: K130912
Trade/Device Name: OMNICUT Resection Blade Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: April 11, 2013 Received: April 12, 2013
Dear Ms. Korsunsky:
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. Tatyana Korsunsky
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.
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 vours. FOR
Peter Dinkumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation. Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): K130912
Device Name: OMNICUT® Resection Blade
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.
| Prescription Use | AND/OR |
|---|---|
| ↓ |
(Part 21 CFR 801 Subpart D)
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 1 of 1
| DSD—DIVISION SIGN-OFF | Joshua C. |
|---|---|
| Division of Surgical Devices | Nipper-S |
| 510(k) Number: | K130912 |