(116 days)
Not Found
Not Found
No
The device description and performance studies focus on the mechanical and optical properties of a rigid arthroscope for visualization, with no mention of AI or ML capabilities.
No
The device is described as an arthroscope used for visualization during surgery, not for treating a disease or condition.
No
The device is described as providing visualization during surgery, acting as a tool for observation rather than making a diagnosis. Its function is to allow surgeons to see inside a joint, not to interpret signs or symptoms to identify a disease or condition.
No
The device description clearly details a physical, rigid arthroscope with mechanical components (direction of view dial, eyepiece, light post) and requires cleaning and sterilization, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "visualization during surgery" in arthroscopic procedures. This is a direct visualization tool used during a surgical procedure on a patient's body.
- Device Description: The description details a rigid arthroscope with optical components for viewing inside a joint. It's a surgical instrument.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not interact with specimens outside the body for diagnostic purposes.
The device is a surgical instrument used for direct visualization within the body during a procedure, not for in vitro diagnostic testing of specimens.
N/A
Intended Use / Indications for Use
Mitek Sports Medicine Arthroscopes are indicated for use in arthroscopic procedures (such as the knee, shoulder, hip, ankle, elbow) to provide visualization during surgery.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
The Mitek Arthroscope is a multi-angle, rigid 4.3 mm arthroscope that has the capability of varying direction of view from 10° to 90° which enables surgeons to maximize and optimize their field of view inside the joint from any given port. This reduces the need for multiple fixed-angle arthroscopes. The direction of view is altered by the direction of view dial; the direction of view is indicated by markings on the scope body. The Mitek Arthroscope provides a 55° field of view and a depth of field from 5mm to 40mm. The device shaft can also rotate by rotating the device (typically by the light post). A standard eyepiece located on the proximal end of the device is compatible with a standard camera coupler. The light post on the subject device is compatible with an ACMI light source. There are two light post stainless steel adaptors that accompany the Mitek Arthroscope. Two adapters are provided to facilitate connection with medical light source cables with a diameter of 5.0mm and smaller. The Mitek Arthroscope is a reusable device and must be cleaned and sterilized according to the user manual prior to every use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, hip, ankle, elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
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 tests of the Mitek Arthroscope included performance, cleaning validation and biocompatibility to show that the device meets its product specifications over a range of operating conditions. Verification testing conforms to the following Standards and Guidance documents listed in Table 2: EN 60601-18, ANSI/AAMI/ISO 17665-1, ISO 11135-01, ISO 10993-1, ISO 17664, IEC 60601-1-2, DIN ISO 8600-3:2004.
Summary of Testing (Table 3) results:
Test / Results
Field of View / Passed
Fixed Focus / Passed
Direction of View Range / Passed
Direction of View Torque / Passed
Rotation of View / Passed
Illumination / Passed
Scope Resolution / Passed
Visual Inspection / Not given
Hermetic sealing / Passed
Free from aberrations / Passed
Results of performance testing have demonstrated that the proposed device is suitable for its intended use.
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.
Not Found
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
510(k) SUMMARY
K133941 Page 1 of 4 APR 1 8 2014
Mitek Arthroscope
.
| Recognized Manufacturer: | Medos International SarL
Puits Godet 20
CH 2000 Neuchâtel
Switzerland | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Submitter: | DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 | |
| Contact Person | Susan Kagan
Project Manager,
Regulatory Affairs
DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA | Telephone: 508-880-8097
Facsimile: 508-977-6911
e-mail: SKagan@its.jnj.com |
| Name of Medical Device | Proprietary Name: SwingScope
Classification Name: Arthroscope
Common Name: Arthroscope | |
| Substantial Equivalence | Mitek Arthroscopes are substantially equivalent to the predicate devices listed in Table1.
Table 1: Predicate Devices | |
Premarket Notification: Traditional 510(k) Mitek Arthroscopes
Page 1
1
| Device
| Classification | Classification: | Class II |
|---|---|---|
| FDA Product Code: | HRX Arthroscope | |
| Regulation: | 21 CFR 888.1100 |
Device The Mitek Arthroscope is a multi-angle, rigid 4.3 mm arthroscope that Description has the capability of varying direction of view from 10° to 90° which enables surgeons to maximize and optimize their field of view inside the joint from any given port. This reduces the need for multiple fixed-angle arthroscopes.
The direction of view is altered by the direction of view dial; the direction of view is indicated by markings on the scope body. The Mitek Arthroscope provides a 55° field of view and a depth of field from 5mm to 40mm. The device shaft can also rotate by rotating the device (typically by the light post). A standard eyepiece located on the proximal end of the device is compatible with a standard camera coupler. The light post on the subject device is compatible with an ACMI light source.
There are two light post stainless steel adaptors that accompany the Mitek Arthroscope. Two adapters are provided to facilitate connection with medical light source cables with a diameter of 5.0mm and smaller.
The Mitek Arthroscope is a reusable device and must be cleaned and sterilized according to the user manual prior to every use.
Indications Mitek Sports Medicine Arthroscopes are indicated for use in arthroscopic for Use procedures (such as the knee, shoulder, hip, ankle, elbow) to provide visualization during surgery.
Non-Clinical No clinical studies are required to demonstrate safety and efficacy of the Testing device in support of an application for premarket clearance. The Mitek Arthroscope does not differ from the predicate device in fundamental scientific technology or intended use.
Verification tests of the Mitek Arthroscope included performance, cleaning validation and biocompatibility to show that the device meets its product specifications over a range of operating conditions.
Premarket Notification: Traditional 510(k) Mitek Arthroscopes
Page 2
2
.
Verification testing conforms to the following Standards and Guidance documents listed in Table 2.
| Safety and
Performance | Standard/
Guidance | Description |
|---------------------------|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | EN 60601-18 | Medical electrical equipment -- Part 18: Particular Requirements
for Basic Safety and Essential performance of endoscopic
equipment |
| | ANSI/AAMI/ISO
17665-1 | Sterilization of Healthcare Products-Moist Heat-Part 1:
Requirements For The Development, Validation And Routine
Control Of A Sterilization Process For Medical Devices |
| | ISO 11135-01 | Sterilization of health care products - Ethylene oxide - Part 1:
Requirements for development, validation and routine control of
a sterilization process for medical devices |
| | ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and
testing |
| | ISO 17664 | Sterilization of medical devices. Information to be provided by the
manufacturer for the processing of re sterilizable medical device |
| | IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests |
| | DIN ISO 8600-
3:2004 | Optics and optical instruments -- Medical endoscopes and
endoscopic accessories -- Part 3: Determination of field of view
and direction of view of endoscopes with optics |
Table 3 provides a summary of testing parameters and results.
| Table 3. Summary of Testing | |
|---|---|
| Test | Results |
| Field of View | Passed |
| Fixed Focus | Passed |
| Direction of View Range | Passed |
| Direction of View Torque | Passed |
| Rotation of View | Passed |
| Illumination | Passed |
| Scope Resolution | Passed |
| Visual Inspection | |
| Hermetic sealing | Passed |
Table 3. Summary of Testing
Premarket Notification: Traditional 510(k) Mitek Arthroscopes
.
Page 3
.
3
| Free from aberrations | Passed |
|---|---|
| Results of performance testing have demonstrated that the proposed | |
| device is suitable for its intended use. |
Based on the indications for use, technological characteristics, and comparison to the predicate devices, the proposed The Mitek Arthroscope has shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.
Premarket Notification: Traditional 510(k) Mitek Arthroscopes
Page 4
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an abstract eagle.
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
April 18, 2014
Medos International SARL - DePuy Mitek Incorporated Ms. Susan Kagan Project Manager Regulatory Affairs 325 Paramount Drive Ravnham, Massachusetts 02767
Re: K133941
Trade/Device Name: Arthroscopes (SwingScope) Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HR X Dated: March 4, 2014 Received: March 10, 2014
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 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 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
5
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 Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
K133941 510(k) Number (if known):
Device Name: Mitek Arthroscopes
Indications for Use:
Mitek Sports Medicine Arthroscopes are indicated for use in arthroscopic procedures (such as the knee, shoulder, hip, ankle, elbow) to provide visualization during surgery.
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)
Joshua C. Nipper -S
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