(208 days)
Not Found
No
The device description and performance studies focus on mechanical aspects and sample collection, with no mention of AI or ML technologies.
No
This device is designed to collect samples from the fallopian tube for diagnostic evaluation (cytological evaluation), not to provide treatment or therapy. It is an accessory for a hysteroscope used in a diagnostic procedure.
No
The device is intended to obtain samples for cytological evaluation, not to perform the evaluation itself. The cytological evaluation, which would be the diagnostic step, is performed on the samples the device collects.
No
The device description explicitly details physical components like a catheter, handle, balloon, shaft, sheath, and knob, indicating it is a hardware device.
Based on the provided information, the MAKO 7 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The MAKO 7's intended use is to obtain samples from the fallopian tube. It is a tool for sample collection, not for the analysis or examination of the sample itself.
- The device description clearly outlines its function as a physical instrument for collecting cells. It describes the catheter, balloon, and handle, all of which are components for physically interacting with the tissue to gather a sample.
- The performance studies mentioned relate to the physical properties of the device (bending, pulling, balloon function) and its ability to navigate anatomy and obtain a sample. These are not studies related to the analytical performance of an IVD device (e.g., sensitivity, specificity of a test).
- The intended use explicitly states the sample is for "cytological evaluation." This evaluation would be performed separately in a laboratory using techniques appropriate for analyzing the collected cells. The MAKO 7 is the instrument that provides the sample for this evaluation.
In summary, the MAKO 7 is a medical device used for sample collection, which is a step that precedes the in vitro diagnostic process. The cytological evaluation itself would be the IVD activity, performed on the sample obtained by the MAKO 7.
N/A
Intended Use / Indications for Use
The MAKO 7 is a hysteroscope accessory, placed through the working channel of a hysteroscope to obtain samples from the fallopian tube for cytological evaluation.
Product codes
HIH
Device Description
The MAKO 7 is a hysteroscope accessory intended to collect cell samples from the fallopian tube. The device is comprised of a catheter and a handle. The catheter includes a balloon, a shaft (which is made up of a stainless-steel tube and a Nylon tube), a sheath (Nylon 12), and a sheath knob (Polycarbonate).
The catheter shaft has 3 markers to facilitate ease of use: the distal marker at the tip of the device, the retraction marker in the middle of the shaft, and the preparation (prep) marker near the proximal end. The handle includes a drive wheel and a luer that attaches to a commercially available inflation device via a stopcock.
In summary, the physician inserts the MAKO 7 into the working channel of the hysteroscope until the distal tip of the catheter is positioned immediately proximal to the ostium of the fallopian tube. Then, the balloon is advanced into the fallopian tube and cells are collected on its surface.
The MAKO 7 is a sterile, single-use device. The device is terminally sterilized using ethylene oxide (EO).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fallopian tube
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
No performance testing is required to evaluate the update of the Instructions for Use (IFU) to modify a warning that was previously listed and make an update to the directions for use section related to the updated warning. Performance testing for bending (kink resistance), pulling (tensile testing), balloon extension length and presence of leaks submitted for currently cleared MAKO 7 (K160510) is applicable to the subject device.
Clinical performance data which demonstrated ability to navigate the target anatomy and obtain a sample sufficient for cytological evaluation submitted for currently cleared MAKO 7 (K160510) is applicable to the subject device.
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
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. 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 § 884.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 21, 2019
Boston Scientific Corporation Ibhina Sherchan Principal Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K182975
Trade/Device Name: MAKO 7 Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope And Accessories Regulatory Class: Class II Product Code: HIH Dated: April 10, 2019 Received: April 11, 2019
Dear Ibhina Sherchan:
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
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sharon M. Andrews Assistant Division Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182975
Device Name MAKO 7
Indications for Use (Describe)
The MAKO 7 is a hysteroscope accessory, placed through the working channel of a hysteroscope to obtain samples from the fallopian tube for cytological evaluation.
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)
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510(k) Summary for MAKO 7
A. Date Prepared
October 24, 2018
B. Submitter
Boston Scientific Corporation Urology and Pelvic Health Division 100 Boston Scientific Way Marlborough, MA 01752
C. Contact
Primary Contact: Ibhina Sherchan Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Tel: (508) 683-4215 Fax: (508) 683-5041 Email: Ibhina.Sherchan@bsci.com
Secondary Contact: Lisa Sullivan Director, Regulatory Affairs Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Tel: (508) 683-4745 Fax: (508) 683-5041 Email: Lisa.Sullivan@bsci.com
D. Device Name
Trade name: Common/usual name: Classification Name:
MAKO 7
Hysteroscope Accessory HIH - Hysteroscope and accessories Obstetrics/Gynecology 21 CFR 884.1690, Class II
E. Predicate Device
Trade name: Common/usual name: MAKO 7 Hysteroscope Accessory
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| Classification Name: | HIH - Hysteroscope and accessories
Obstetrics/Gynecology
21 CFR 884.1690, Class II |
|----------------------|------------------------------------------------------------------------------------------|
| 510(k) number: | K160510 |
The predicate device has not been subject to a design related recall.
F. Device Description
The MAKO 7 is a hysteroscope accessory intended to collect cell samples from the fallopian tube. The device is comprised of a catheter and a handle. The catheter includes a balloon, a shaft (which is made up of a stainless-steel tube and a Nylon tube), a sheath (Nylon 12), and a sheath knob (Polycarbonate).
The catheter shaft has 3 markers to facilitate ease of use: the distal marker at the tip of the device, the retraction marker in the middle of the shaft, and the preparation (prep) marker near the proximal end. The handle includes a drive wheel and a luer that attaches to a commercially available inflation device via a stopcock.
In summary, the physician inserts the MAKO 7 into the working channel of the hysteroscope until the distal tip of the catheter is positioned immediately proximal to the ostium of the fallopian tube. Then, the balloon is advanced into the fallopian tube and cells are collected on its surface.
The MAKO 7 is a sterile, single-use device. The device is terminally sterilized using ethylene oxide (EO).
G. Intended/Indications for Use
The MAKO 7 is a hysteroscope accessory, placed through the working channel of a hysteroscope to obtain samples from the fallopian tube for cytological evaluation. The subject and predicate device have identical Indications for Use.
H. Technological Characteristics
The mechanism of action and principles of operation of the subject device and the predicate device are identical. Both devices use an identical handle, catheter body, balloon length, and, most distally, a balloon that collects the sample. For both devices, this distal portion is actuated by a drive wheel on the handle and a hysteroscopic view is required. The proposed MAKO 7 device has the same technical characteristics as its predicate, the currently cleared MAKO 7 (K160510).
I. Performance Data
No performance testing is required to evaluate the update of the Instructions for Use (IFU) to modify a warning that was previously listed and make an update to the directions for use section related to the updated warning. Performance testing
5
for bending (kink resistance), pulling (tensile testing), balloon extension length and presence of leaks submitted for currently cleared MAKO 7 (K160510) is applicable to the subject device.
Clinical performance data which demonstrated ability to navigate the target anatomy and obtain a sample sufficient for cytological evaluation submitted for currently cleared MAKO 7 (K160510) is applicable to the subject device.
J. Conclusion
The information provided in this submission demonstrates that the proposed MAKO 7 device is substantially equivalent to the predicate device MAKO 7, cleared in K160510.