(184 days)
Not Found
No
The device description and performance studies focus on mechanical and clinical performance, with no mention of AI/ML algorithms or data processing for decision-making or analysis.
No
The device is described as an accessory for a hysteroscope used to obtain samples for cytological evaluation, which is a diagnostic purpose, not a therapeutic one.
No
The device is an accessory used to obtain samples for cytological evaluation, but it does not perform the evaluation itself, which would be the diagnostic step.
No
The device description explicitly details physical components like a catheter, handle, balloon, shaft, and sheath, indicating it is a hardware device, not software-only.
Based on the provided information, the MAKO Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to obtain samples from the proximal fallopian tube for cytological evaluation. The device itself is a tool for sample collection, not for performing the diagnostic test on the sample.
- Device Description: The description details a mechanical device for collecting cells. It does not describe reagents, test strips, or any components that would be used to perform a diagnostic test in vitro (outside the body).
- Function: The device's function is to physically collect cells. The diagnostic evaluation (cytological evaluation) is performed after the sample is collected, likely in a laboratory setting using other methods and equipment.
An IVD device is typically a medical device intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. The MAKO Device facilitates the collection of the specimen, but it does not perform the diagnostic examination itself.
N/A
Intended Use / Indications for Use
The MAKO Device is a hysteroscope accessory, placed through the working channel of a hysteroscope to obtain samples from the proximal fallopian tube for cytological evaluation.
Product codes
HIH
Device Description
The MAKO Device is a hysteroscope accessory intended to collect cell samples from the proximal 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 handle includes a drive wheel and an extension tube that is attached to a luer in the handle body. The extension tube attaches to a commercially available inflation device via a commercially available 3-way stopcock.
In summary, the physician inserts the MAKO Device 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 proximal portion of the fallopian tube and cells are collected on its surface.
The MAKO Device 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
Hysteroscopic visualization
Anatomical Site
proximal fallopian tube
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician / hospital/clinic/physician's office.
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)
Biocompatibility testing
- Cytotoxicity
- Vaginal irritation
- Sensitization
Mechanical testing
- Dimensional (sample size of n=15 was used for each test)
- Tensile strength of balloon, catheter, and shaft components (sample size of n=15 was used for each test)
- Simulated use testing in a uterine model, including compatibility with inflation device, compatibility with hysteroscope, and ability to access proximal fallopian tube (sample size of n=29 was used)
- Balloon inflation pressure (sample size of n=29 was used)
- Device deployment (sample size of n=15 was used)
Shelf Life Testing
Accelerated aging testing was conducted on the subject device to substantiate a shelf life of one year. The shelf life study was performed following sterilization in the original packaging. The following device specifications were evaluated in the accelerated aging study to demonstrate the subject device maintains its specifications throughout the duration of its shelf life:
- Seal integrity (visual assessment)
- Pouch leakage
- Seal strength
- Device dimensions
- Inflation pressure
- Inflated balloon dimensions
- Tensile strength (balloon, catheter, and shaft components)
Human factors and usability testing
- Physician feedback on handle ergonomics, drive wheel ergonomics, hysteroscopic visibility of balloon deployment, and ability to follow IFU
- A sample size of 3 to 7 physicians per parameter was used
Clinical testing
A prospective, single-arm clinical study was conducted to demonstrate the safety and effectiveness of the subject device in navigating the proximal fallopian tube and obtaining cell samples. A total of 40 women (80 fallopian tubes), previously scheduled to undergo a tubal ligation, were enrolled in the study. The following performance characteristics were evaluated in the study:
- Safety
- Device Performance
- Ability of device to access target anatomy
- Ability of the device to collect samples
- Ability to obtain samples that are adequate for cytological evaluation
The results demonstrated that the subject device was successfully able to navigate the fallopian tubes (75/80 successful) and collect adequate cell samples for cytology (adequate samples in 71/75 of accessible tubes). A single fallopian tube perforation, requiring no further medical intervention, was noted in one subject. Pre-existing proximal tubal occlusion was confirmed in this subject.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Device success in navigating fallopian tubes: 75/80 successful
- Device success in collecting adequate samples for cytology: 71/75 of accessible tubes
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2015
Nvision Medical % Cindy Domecus Principal Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, California 94010
Re: K151275
Trade/Device Name: MAKO Device Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope And Accessories Regulatory Class: Class II Product Code: HIH Dated: October 14, 2015 Received: October 15, 2015
Dear Cindy Domecus:
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
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151275
Device Name MAKO Device
Indications for Use (Describe)
The MAKO Device is a hysteroscope accessory, placed through the working channel of a hysteroscope to obtain samples from the proximal fallopian tube for cytological evaluation.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the word "nVision" in black font, with a light blue circle in place of the "V". The "n" is lowercase, while the rest of the word is in uppercase. The logo appears to be for a company or product called "nVision".
510(k) Summary
SUBMITTER I.
510(k) Owner: nVision Medical 250 King St, #676 San Francisco, CA 94107 Surbhi Sarna, CEO Telephone: (408) 655-3577 surbhi@nvisionmedical.com
Contact Person: Cindy Domecus, R.A.C. (US &EU) Principal, Domecus Consulting Services LLC (650) 343-4813 (phone) (650) 343-7822 (fax) DomecusConsulting@comcast.net
Date Prepared: May 11, 2015
II. DEVICE
| Name of Device: | MAKO Device |
|---|---|
| Common or Usual Name: | Hysteroscope Accessory |
| Classification Name: | Hysteroscope and accessories (884.1690) |
| Regulatory Class: | II |
| Product Code: | HIH |
III. PREDICATE DEVICE
Substantial equivalence was claimed to the following predicate device:
| 510(k) Number,
Company | Trade Name | Model
Number |
|---------------------------|-------------------------------|-----------------|
| K132384
EndoSee | U-Scope™ 8000 HSC+EMB Cannula | 8000 |
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Image /page/4/Picture/0 description: The image shows the logo for Nvision. The logo consists of the letter 'n' in black, followed by a light blue circle with a white 'V' shape inside. The rest of the word 'vision' is written in black to the right of the circle. The font is sans-serif and appears to be bolded.
IV. DEVICE DESCRIPTION
The MAKO Device is a hysteroscope accessory intended to collect cell samples from the proximal 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 handle includes a drive wheel and an extension tube that is attached to a luer in the handle body. The extension tube attaches to a commercially available inflation device via a commercially available 3-way stopcock.
In summary, the physician inserts the MAKO Device 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 proximal portion of the fallopian tube and cells are collected on its surface.
The MAKO Device is a sterile, single-use device. The device is terminally sterilized using ethylene oxide (EO).
The device is intended for use in the hospital/clinic/physician's office. The duration and type of contact is classified as follows:
- Category: External Communicating Device ●
- Contact: Mucosal membrane ●
- Duration: A Less than 24 hours ●
INTENDED USE/INDICATIONS FOR USE V.
The indications for use for the subject device are as follows:
The MAKO Device is a hysteroscope accessory, placed through the working channel of a hysteroscope to obtain samples from the proximal fallopian tube for cytological evaluation.
The indications for use are different than the predicate, in that the indication for use for the subject device 1) does not contain information pertaining to indications for the hysteroscope, as the device does not include a hysteroscope, but rather, is used through the working channel of a commercially available hysteroscope, and 2) refers to the collection of samples from the proximal fallopian tube instead of the uterus.
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Image /page/5/Picture/0 description: The image shows the word "nVision" with a stylized "V". The "n" is in black, the "V" is a light blue circle with a white "V" in the center, and the "ision" is in black. The font is sans-serif and the text is left-aligned. The image is simple and clean.
Not including information pertaining to the indications for use for the hysteroscope is not a substantive issue, as the subject device will be used through the working channel of a commercially available hysteroscope, which will include indications for use for the hysteroscope that were cleared by FDA.
Since the proximal fallopian tube represents a different anatomical location than the uterus, the FDA guidance document, "General/Specific Intended Use," (issued November 4, 1998) was used to determine whether the intended use of the subject device falls within the scope of the predicate device. Indications for use that specify a particular anatomical site, but do not imply diagnosis or therapy of a specific disease entity, typically fall within the scope of the general intended use for the purposes of determining substantial equivalence. When the decision-making criteria from the guidance are applied, the intended use comparison between the subject and predicate devices supports equivalence. In regards to risk, the specific use of the subject device does not introduce new risks not normally associated with endometrial sampling procedures. Furthermore, the proximal fallopian tube is housed within the uterine wall, so it is contiguous with the uterus. Therefore, the collection of samples from the proximal fallopian tube compared to the uterus does not represent a new intended use.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VI.
The mechanism of action of the subject device and the predicate device is similar in that both devices extract samples from the reproductive tract by scraping against the tissue of the target anatomy. The devices are also similar in that they consist of a handle, cannula/catheter body, and, most distally, a portion that collects the sample. For all devices, this distal portion is actuated by a mechanism on the handle and a hysteroscopic view is required.
For the subject device and predicate devices, the handle is meant to 1) provide an ergonomic way of gripping the device under hysteroscopic visualization, and 2) to actuate the distal portion of the device. which then collects the sample. The cannula/catheter body of the devices is meant to provide the device stability and reach as it is placed through the working channel of the hysteroscope.
The most pertinent technological assessment is the distal end of the predicate and subject devices; specifically, the portion of the device meant to collect the sample. The primary difference between the subject and predicate devices is that the subject device uses a balloon to achieve access to the fallopian tube and to collect cells, while the U-Scope device scrapes against the uterine wall with a curette. However, the technological characteristics of the subject device do not introduce new risks when compared to the uterine sampling mechanism of the predicate device. For the subject device, wrinkles in the balloon that form as the balloon deflates create multiple edges in order to collect samples. These edges work in a manner similar to the edges of the curette of the U-Scope predicate device. Therefore, the above technological differences do not raise different questions of safety or effectiveness, as the risks associated with using the subject and predicate devices (i.e., uterine
CONFIDENTIAL
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Image /page/6/Picture/0 description: The image shows the word "nVision" in black font, with the "V" in "Vision" being a light blue color. The "n" is lowercase, while the rest of the letters are uppercase. The logo is simple and modern.
perforation) are the same.
PERFORMANCE DATA VII.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
- Cytotoxicity
- Vaginal irritation ●
- Sensitization
Mechanical testing
- Dimensional (sample size of n=15 was used for each test)
- Tensile strength of balloon, catheter, and shaft components (sample size of n=15 was used for each test)
- Simulated use testing in a uterine model, including compatibility with inflation device, compatibility with hysteroscope, and ability to access proximal fallopian tube (sample size of n=29 was used)
- . Balloon inflation pressure (sample size of n=29 was used)
- Device deployment (sample size of n=15 was used) ●
Shelf Life Testing
Accelerated aging testing was conducted on the subject device to substantiate a shelf life of one year. The shelf life study was performed following sterilization in the original packaging. The following device specifications were evaluated in the accelerated aging study to demonstrate the subject device maintains its specifications throughout the duration of its shelf life:
- Seal integrity (visual assessment) ●
- Pouch leakage
- Seal strength
- Device dimensions
- Inflation pressure ●
- Inflated balloon dimensions ●
- Tensile strength (balloon, catheter, and shaft components) .
Human factors and usability testing
- o Physician feedback on handle ergonomics, drive wheel ergonomics, hysteroscopic visibility of balloon deployment, and ability to follow IFU
- A sample size of 3 to 7 physicians per parameter was used .
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Image /page/7/Picture/0 description: The image shows the word "nVision" in black font. The "n" is lowercase, and the "V" is partially covered by a light blue circle. The rest of the word is in lowercase.
Clinical testing
A prospective, single-arm clinical study was conducted to demonstrate the safety and effectiveness of the subject device in navigating the proximal fallopian tube and obtaining cell samples. A total of 40 women (80 fallopian tubes), previously scheduled to undergo a tubal ligation, were enrolled in the study. The following performance characteristics were evaluated in the study:
- Safetv
- Device Performance
- Ability of device to access target anatomy
- Ability of the device to collect samples ●
- Ability to obtain samples that are adequate for cytological evaluation ●
The results demonstrated that the subject device was successfully able to navigate the fallopian tubes (75/80 successful) and collect adequate cell samples for cytology (adequate samples in 71/75 of accessible tubes). A single fallopian tube perforation, requiring no further medical intervention, was noted in one subject. Pre-existing proximal tubal occlusion was confirmed in this subject.
VIII. CONCLUSION
The bench and clinical performance data provided in support of the 510(k) confirm that the subject device is as safe and effective and substantially equivalent to the predicate device.