(262 days)
No
The device description focuses on rigid scopes, sheaths, and obturators for visual examination during arthroscopy, with no mention of AI/ML capabilities or image processing beyond providing magnified images. The performance studies are related to physical characteristics and cleaning/sterilization, not algorithmic performance.
No.
The device is used to examine human joints from the inside during arthroscopic diagnostic procedures and provides magnified images, which indicates a diagnostic function rather than a therapeutic one.
Yes
The "Intended Use / Indications for Use" states that the MectaScope System is used "during arthroscopic diagnostic procedures". This directly indicates its use for diagnosis.
No
The device description explicitly lists physical components such as rigid scopes, sheaths, and obturators made of stainless steel and EPDM, indicating it is a hardware device.
Based on the provided information, the MectaScope System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological or pathological state. This testing is done outside the body (in vitro).
- MectaScope System's Function: The MectaScope System is used to directly examine human joints inside the body during arthroscopic procedures. It provides visual information to the surgeon in real-time. This is an in vivo diagnostic procedure, not in vitro.
- Intended Use: The intended use clearly states it's for examining human joints "from the inside during arthroscopic diagnostic procedures."
- Device Description: The description details rigid scopes, sheaths, and obturators used for direct visualization within the joint cavity.
Therefore, the MectaScope System is a surgical instrument used for direct visualization within the body, not a device that analyzes specimens outside the body.
N/A
Intended Use / Indications for Use
MectaScope System is used to examine human joints such as knee and shoulder from the inside during arthroscopic diagnostic procedures, providing surgeons with magnified images on a monitor.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
The MectaScope System is comprised of rigid scopes use to examine joints, a sheath used to access the surgical site, and obturators to facilitate the initial access of the sheath into the joint cavity in preparation for arthroscopic procedures. The rigid scopes, manufactured primarily from stainless steel, provide a circular field of view and are available in two (2) different directions of view, 30° and 70°. The sheath, manufactured from stainless steel and EPDM, is introduced into the joint using the obturators and maintains a stable portal during the arthroscopic procedure. The obturators, manufactured with stainless steel and EPDM, are provided with or without a handle; the obturator with a handle is compatible with a Ø 1.5 mm k-wire. The MectaScope System components are provided non-sterile and are reusable. The MectaScope scopes are designed to be used with legally marketed camera and control units and are connected to legally marketed available light-guide cables via the light connector (designed in accordance with ISO 18339). Manufacturer specific light guide adapters are provided with the MectaScope System including adapters for Olympus/Storz, Richard Wolf, and ACMI light guide cables.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human joints such as knee and shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons / 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)
Testing was conducted according to written protocols with acceptance criteria that were based on standards. The following mechanical studies were performed on worst-case device configurations in support of a substantial equivalence determination:
Comparative study
- . Design Validation Report, Scope and Sheath - KARL STORZ Arthroscope Sheath;
- o comparison of fluid passage (volume unit per time) with the MectaScope Rotating Sheath and the KARLSTORZ Arthroscope Sheath, utilizing a rotating spigot plane
Non-Clinical Studies:
- visual field and viewing direction testing per ISO 8600;
- concentricity test per ISO 18339;
- cadaver testing; and
- cleaning and sterilization validation.
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.
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
October 1, 2020
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Medacta International SA Chris Lussier Senior Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis. Tennessee 38118
Re: K200067
Trade/Device Name: MectaScope System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: September 1, 2020 Received: September 3, 2020
Dear Chris Lussier:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Pooja Panigrahi -S
for
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name MectaScope System
Indications for Use (Describe)
MectaScope System is used to examine human joints such as knee and shoulder from the inside during arthroscopic diagnostic procedures, providing surgeons with magnified images on a monitor.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
I. Submitter
Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
Contact Person: Stefano Baj, Regulatory Affairs and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director, Quality and Regulatory, Medacta USA Date Prepared: January 13, 2020 Date Revised: September 29, 2020
II. Device
| Device Proprietary Name: | MectaScope System |
|---|---|
| Common or Usual Name: | Arthroscope |
| Classification Name: | Arthroscope |
| Product Codes: | HRX |
| Regulation Number: | 21 CFR 888.1100 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following device:
- Arthroscopic Telescopes, K943052, Karl Storz Endoscopy .
IV. Reference Device
- KSEA Large Joint Arthroscopy Set, K963524, Karl Storz Endoscopy ●
V. Device Description
The MectaScope System is comprised of rigid scopes use to examine joints, a sheath used to access the surgical site, and obturators to facilitate the initial access of the sheath into the joint cavity in preparation for arthroscopic procedures.
The rigid scopes, manufactured primarily from stainless steel, provide a circular field of view and are available in two (2) different directions of view, 30° and 70°. The sheath, manufactured from stainless steel and EPDM, is introduced into the joint using the obturators and maintains a stable portal during the arthroscopic procedure. The obturators, manufactured with stainless steel and
4
EPDM, are provided with or without a handle; the obturator with a handle is compatible with a Ø 1.5 mm k-wire. The MectaScope System components are provided non-sterile and are reusable.
The MectaScope scopes are designed to be used with legally marketed camera and control units and are connected to legally marketed available light-guide cables via the light connector (designed in accordance with ISO 18339). Manufacturer specific light guide adapters are provided with the MectaScope System including adapters for Olympus/Storz, Richard Wolf, and ACMI light guide cables.
VI. Indications for Use
MectaScope System is used to examine human joints such as knee and shoulder from the inside during arthroscopic diagnostic procedures, providing surgeons with magnified images on a monitor.
VII. Comparison of Technological Characteristics
The MectaScope System and the predicate device share the following characteristics:
- arthroscope working length, diameter, field of view, and direction of view; .
- sheath design: ●
- . eyepiece design;
- materials of construction; and
- connection to legally marketed camera systems and light guide cables.
The MectaScope System and the predicate devices are technologically different with respect to the design of connections between system components, camera, and fiber optic cable, as well as sheath and obturator design.
A comparison of key technological features between the subject and predicate device is provided in the table below.
| | MectaScope System | Arthroscopic Telescopes
(K943052) |
|-------------------|-------------------|--------------------------------------|
| Arthroscope | | |
| Type of scope | Rigid | Rigid |
| Outer diameter | 4 mm | 4 mm |
| Field of view | circular | circular |
| Direction of view | 30° and 70° | 30° and 70° |
| Reusable | Yes | Yes |
Discussion
Although slight differences in design with respect to connections and obturator design exist, these differences do not raise different questions of safety and effectiveness as the products utilizing the
5
same fundamental scientific technology. Design verification testing was undertaken and demonstrates that the subject device performs to specification and as intended.
VIII. Performance Data
Testing was conducted according to written protocols with acceptance criteria that were based on standards. The following mechanical studies were performed on worst-case device configurations in support of a substantial equivalence determination:
Comparative study
- . Design Validation Report, Scope and Sheath - KARL STORZ Arthroscope Sheath;
- o comparison of fluid passage (volume unit per time) with the MectaScope Rotating Sheath and the KARLSTORZ Arthroscope Sheath, utilizing a rotating spigot plane
Non-Clinical Studies:
- visual field and viewing direction testing per ISO 8600; ●
- concentricity test per ISO 18339;
- cadaver testing; and
- cleaning and sterilization validation. ●
IX. Conclusion
The information provided with this submission supports that the MectaScope System is substantially equivalent to the identified predicate device.
Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations.