(208 days)
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 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).
This document is a 510(k) summary for the MAKO 7 hysteroscope accessory, which is a re-submission of an already cleared device, K160510. This current submission (K182975) is for an update to the Instructions for Use (IFU) to modify a warning and update related directions for use. Therefore, no new performance data was generated for the current submission as the existing performance data from K160510 is considered applicable.
Here's a breakdown of the requested information based on the provided text, noting that much of it points to the previous submission (K160510) as the source of the data:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text for K182975 does not detail specific acceptance criteria or quantitative performance results for the MAKO 7. It states that "No performance testing is required to evaluate the update of the Instructions for Use (IFU)." Instead, it refers to performance data submitted for the currently cleared MAKO 7 (K160510).
The types of performance testing mentioned as being applicable from K160510 include:
| Test Category | Specific Test (from K160510) | Reported Device Performance (from K160510) |
|---|---|---|
| Mechanical Performance | Bending (kink resistance) | (Not specified in this document) |
| Pulling (tensile testing) | (Not specified in this document) | |
| Balloon extension length | (Not specified in this document) | |
| Presence of leaks | (Not specified in this document) | |
| Clinical Performance | Ability to navigate anatomy | (Not specified in this document) |
| Obtain sample for cytological evaluation | (Not specified in this document) |
2. Sample Size Used for the Test Set and the Data Provenance
The document for K182975 does not provide sample sizes or data provenance for a test set, as no new performance testing was conducted for this submission. It references "Clinical performance data... submitted for currently cleared MAKO 7 (K160510)". To get details about the sample size and provenance, one would need to consult the K160510 submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the K182975 submission. The document mentions "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)", but does not specify how ground truth was established or the experts involved.
4. Adjudication Method for the Test Set
This information is not provided in the K182975 submission, as no new performance testing was conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
This question is not applicable. The MAKO 7 device is described as a "hysteroscope accessory" for collecting cell samples, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance in a diagnostic context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable. The MAKO 7 is a physical medical device (an accessory for a hysteroscope), not an algorithm or software-only device.
7. The Type of Ground Truth Used
The clinical performance data mentioned is related to the device's ability to "navigate the target anatomy and obtain a sample sufficient for cytological evaluation." This implies that the ground truth for collected samples would likely be cytological evaluation (pathology) to confirm the sufficiency and quality of the obtained sample. The ability to navigate the anatomy would likely be confirmed by direct observation during a procedure. However, precise details are not available in this document.
8. The Sample Size for the Training Set
This information is not provided in the K182975 submission, as no new performance testing or machine learning models (which typically require training sets) were involved in this submission.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the K182975 submission, as no new performance testing or machine learning models were involved.
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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
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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 accessoriesObstetrics/Gynecology21 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
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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.
§ 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.