(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.
§ 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.