(235 days)
Not Found
No
The summary describes standard image processing and transmission, with no mention of AI, ML, or related concepts like deep learning, neural networks, or algorithms for image analysis beyond basic signal processing.
No
The device is described as being used for "viewing" and "performing diagnostic procedures," including obtaining an endometrial tissue sample for "cytologic and histologic diagnosis." These actions are primarily for diagnosis and observation, not for treating a condition, which is the purpose of therapeutic devices.
Yes
The intended use explicitly states that the device is "used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures." It also lists "Generally recognized indications for diagnostic hysteroscopy."
No
The device description explicitly states that the device consists of a lightweight handle, a cannula integrated with a camera and a light source, and a camera module with a camera and LED lighting. These are physical hardware components, not solely software. While it uses software, it is not a software-only medical device.
Based on the provided information, the Reedgyn disposable hysteroscope RH-2D-01 and RH-2S-01 are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Reedgyn Hysteroscope Function: The Reedgyn hysteroscope is used to view the cervical canal and uterine cavity in vivo (inside the body) and, in the case of the RH-2S-01, to obtain a tissue sample. The device itself is not performing the diagnostic test on the sample.
- Sample Analysis: While the RH-2S-01 obtains a tissue sample, the description explicitly states that "The sample is used for cytologic and histologic diagnosis." This indicates that the diagnostic analysis of the sample is performed separately, likely in a laboratory setting using other IVD devices or procedures.
- Device Description: The device description focuses on the optical and imaging capabilities of the hysteroscope for visualization, not on analyzing biological specimens.
In summary, the Reedgyn disposable hysteroscope is a medical device used for visualization and sample collection within the body. The diagnostic process involving the collected sample occurs outside the body using other methods, making the hysteroscope itself not an IVD.
N/A
Intended Use / Indications for Use
The Reedgyn disposable hysteroscope RH-2D-01 is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures in an outpatient or office setting. Generally recognized indications for diagnostic hysteroscopy include: abnormal bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain.
The Reedgyn disposable hysteroscope RH-2S-01 is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and to obtain an endometrial tissue sample (biopsy) in an outpatient or office setting. The sample is used for cytologic and histologic diagnosis. Generally recognized indications for diagnostic hysteroscopy include: abnormal bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain.
Product codes (comma separated list FDA assigned to the subject device)
HIH
Device Description
The Reedgyn disposable hysteroscopes, which include models RH-2S-01 and RH-2D-01, are used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures (both RH-2S-01 and RH-2D-01) and to obtain an endometrial tissue sample (biopsy) in an outpatient or office setting (RH-2S-01 only).
RH-2S-01 and RH-2D-01 are similar in design. The only difference between RH-2S-01 and RH-2D-01 is: RH-2S-01 is intended for performing diagnostic procedures and obtaining an endometrial tissue sample (biopsy), while the RH-2D-01 is intended for performing diagnostic procedures only.
The Reedgyn disposable hysteroscopes consist of a lightweight handle, a cannula integrated with a camera and a light source at the distal end to illuminate the area for visualizing images. The distal end of the cannula is equipped with a camera module including a camera and LED lightling. LED irradiates the surface of the object, and the reflected light enters the image processor through a lens and converts it into electrical signals, and then converted into a digital image signal , which is transmitted to the digital signal processing chip. After chip processing, the signal is transmitted to PC through USB interface.
The Reedgyn disposable hysteroscopes should be operated together with Reedgyn hysteroscope imaging software which was installed to a Microsoft Windows PC station. (Note: the Windows PC station is not included in the product configuration.)
The Reedgyn disposable hysteroscope is provided sterile sealed pouch. It is for single use.
The Reedgyn disposable hysteroscope operates on 5V DC working voltage.
The general type of materials in the device are PEVAX® thermoplastic elastomers (Cannula) and polycarbonate (Connector). The Reedgyn disposable hysteroscope components are part of an external communicating device (Tissue/bone/dentin) in direct tissue contact for a duration
§ 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 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.
November 18, 2019
Reed Medical (Zhejiang) Co., Ltd. % Daniel Qiu Project Manager Shanghai Qisheng Business Consulting Co., Ltd. Room 1301, Bld 46, Jing Gu Zhong Rd. No. 58, Min Hang District, Shanghai, CN Shanghai, Shanghai 200240 CHINA
Re: K190797 Trade/Device Name: Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope And Accessories Regulatory Class: II Product Code: HIH Dated: October 15, 2019 Received: October 15, 2019
Dear Daniel Oiu:
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
1
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 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 medical devices and radiation-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,
for Sharon Andrews 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) K190797
Device Name
Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)
Indications for Use (Describe)
The Reedgyn disposable hysteroscope RH-2D-01 is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures in an outpatient or office setting. Generally recognized indications for diagnostic hysteroscopy include: abnormal bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain.
The Reedgyn disposable hysteroscope RH-2S-01 is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and to obtain an endometrial tissue sample (biopsy) in an outpatient or office setting. The sample is used for cytologic and histologic diagnosis. Generally recogmized indications for diagnostic hysteroscopy include: abnormal bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain.
| 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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3
510(k) Summary
l. Submitter's information
Name: Reed Medical (Zhejiang) Co., Ltd. Address: 8th floor, 10th building, No.988 of Xinxing two road, EDZ of Pinghu, Pinghu, Zhejiang, China Contact person: Lu Zhong Zhong Telephone: +86-573-85135876 Fax: +86-573-85135876 Date prepared: November 17, 2019
II.Device
Device trade name: Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) Classification name: Hysteroscope and Accessories Regulation class: II Regulation number: 21CFR 884.1690 Panel: Obstetrics/Gynecology Product code: HIH
III.Predicative device
K132384, U-scope 8000 System With Hsc+emb Cannula.
IV.Device description
The Reedgyn disposable hysteroscopes, which include models RH-2S-01 and RH-2D-01, are used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures (both RH-2S-01 and RH-2D-01) and to obtain an endometrial tissue sample (biopsy) in an outpatient or office setting (RH-2S-01 only).
RH-2S-01 and RH-2D-01 are similar in design. The only difference between RH-2S-01 and RH-2D-01 is: RH-2S-01 is intended for performing diagnostic procedures and obtaining an endometrial tissue sample (biopsy), while the RH-2D-01 is intended for performing diagnostic procedures only. Key performance specifications and device characteristics are listed in the table below.
4
The Reedgyn disposable hysteroscopes consist of a lightweight handle, a cannula integrated with a camera and a light source at the distal end to illuminate the area for visualizing images. The distal end of the cannula is equipped with a camera module including a camera and LED lightling. LED irradiates the surface of the object, and the reflected light enters the image processor through a lens and converts it into electrical signals, and then converted into a digital image signal , which is transmitted to the digital signal processing chip. After chip processing, the signal is transmitted to PC through USB interface.
The Reedgyn disposable hysteroscopes should be operated together with Reedgyn hysteroscope imaging software which was installed to a Microsoft Windows PC station. (Note: the Windows PC station is not included in the product configuration.)
| Parameter | Specification |
|---|---|
| Cannula length | 270mm |
| Outer diameter | RH-2D-01: 4.9mm |
| RH-2S-01: 7.8mm | |
| Inner diameter | RH-2D-01: |
| -Fluid channel (In & out): 1.3mm | |
| RH-2S-01: | |
| -Fluid channel (In & out): 1.2mm | |
| -Accessory channel: 2mm | |
| Handle width | 28 mm |
| Handle height | 25 mm |
| Direction of view | 20° ± 5° |
| Field of view | 100° ± 5° |
| Number of pixels | 1280 x 720 |
| Depth of field | 5-50mm |
| Light Source | LED |
The Reedgyn disposable hysteroscope is provided sterilea sealed pouch. It is for single use.
The Reedgyn disposable hysteroscope operates on 5V DC working voltage.
The general type of materials in the device are РЕВАХ® thermoplastic elastomers
5
(Cannula) and polycarbonate (Connector). The The Reedgyn disposable hysteroscope components are part of an external communicating device (Tissue/bone/dentin) in direct tissue contact for a duration ≤24 hours. . The biocompatibility of the Reedgyn disposable hysteroscope was established via testing of the final, finished product (see performance testing section below).
The Reedgyn disposable hysteroscopes are intended to be used in hospitals and physician offices.
V.Indication for use
The Reedgyn disposable hysteroscope RH-2D-01 is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures in an outpatient or office setting. Generally recognized indications for diagnostic hysteroscopy include: abnormal bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain.
The Reedgyn disposable hysteroscope RH-2S-01 is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and to obtain an endometrial tissue sample (biopsy) in an outpatient or office setting. The sample is used for cytologic and histologic diagnosis. Generally recognized indications for diagnostic hysteroscopy include: abnormal bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain.
The indications for use of Reedgyn disposable hysteroscopes are similar to that of predicate device. The indications for the RH-2D-01 falls within the indications of the predicate, but does not include biopsy.
| Attribute | Subject device | Predicative device
U-Scope 8000 Hsc+emb
Cannula |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K190797 | K132384 |
| Indication for use | The Reedgyn disposable hysteroscope RH-2D-01 is
used to permit viewing of the cervical canal and
uterine cavity for the purpose of performing
diagnostic procedures in an outpatient or office
setting. Generally recognized indications for
diagnostic hysteroscopy include: abnormal
bleeding, infertility and pregnancy wastage, | The predicative device is used
to permit viewing of the
cervical canal and uterine
cavity for the purpose of
performing diagnostic
procedures and to obtain an
endometrial tissue sample |
| Attribute | Subject device | Predicative device
U-Scope 8000 Hsc+emb
Cannula |
| | evaluation of abnormal hysterosalpingogram,
intrauterine foreign body, amenorrhea, and pelvic
pain. | (biopsy) in an outpatient or
office setting. The sample is
used for cytologic and
histologic diagnosis. Generally
recognized indications for
diagnostic hysteroscopy
include: abnormal bleeding,
infertility and pregnancy
wastage, evaluation of abnormal
hysterosalpingogram,
intrauterine foreign body,
amenorrhea, and pelvic pain. |
| | The Reedgyn disposable hysteroscope RH-2S-01 is
used to permit viewing of the cervical canal and
uterine cavity for the purpose of performing
diagnostic procedures and to obtain an
endometrial tissue sample (biopsy) in an
outpatient or office setting. The sample is used for
cytologic and histologic diagnosis. Generally
recognized indications for diagnostic hysteroscopy
include: abnormal bleeding, infertility and
pregnancy wastage, evaluation of abnormal
hysterosalpingogram, intrauterine foreign body,
amenorrhea, and pelvic pain. | diagnostic hysteroscopy
include: abnormal bleeding,
infertility and pregnancy
wastage, evaluation of abnormal
hysterosalpingogram,
intrauterine foreign body,
amenorrhea, and pelvic pain. |
| Procedures | Uterine diagnostic for RH-2D-01, Uterine
diagnostic and endometrial biopsy for RH-2S-01 | Uterine diagnostic and
endometrial biopsy |
| Environment of use | Hospitals and physician offices | Hospitals and physician offices |
| Intended user | Physicians with adequate training in hysteroscopy | For use only by physicians
with adequate training in
hysteroscopy. |
| Device features:
-Components | CMOS camera semi-rigid cannula USB interface electronics USB cable | Image-capturing hand tower; attachable cannula with outflow and inflow ports
in which suction can be created and with a curette
near its tip. |
| -Cannula outer
diameter | RH-2S-01: 7.8 mm
RH-2D-01: 4.9 mm | 4.3mm |
| -Accessory channel | RH-2D-01: N/A
RH-2S-01: 2mm | N/A |
| -Cannula | Flexible | Flexible |
| Attribute | Subject device | Predicative device
U-Scope 8000 Hsc+emb
Cannula |
| -Cannula length | 270mm | 276mm |
| -Illumination light
source | LEDs | LEDs |
| -Hysteroscope field
of view | $100° ±5°$ | $100° ±5°$ |
| -Hysteroscope
direction of view | $20° ±5°$ | $20° ±3°$ |
| -Depth of field | 5-50mm | 4-45mm |
| -Imaging
transmission | Over USB interface to a viewing station | Image transmitted from a
video camera to a video
monitor on the handle |
| -Number of pixels | 1280 x 720 | 400*400 |
| -Optical image | Digital CMOS | Digital CMOS technology |
| Disposable/Reusable | Disposable/ only single usage | Reusable handle and a sterile
disposable diagnostic cannula |
| Battery charge
indication | n/a - no battery | Charge indication as an icon on
the LCD monitor |
| Battery
power | n/a - no battery | 3.7V |
| Adjust
brightness of LEDs | n/a - brightness is managed by camera exposure
and gain | Adjust by depressing a button
on the hand tower |
| Capture still or video
images during
procedure | Controlled by keyboard and foot switch interfaces | Capture still or video during
procedure by depressing a
camera button on the hand
tower |
| Enter
patient ID
information prior to
procedure | User interface allows physician to add patient
information | User interface on monitor
allows physician to add patient
information. |
| Duration
of use | $≤$ 2 hours | $≤$ 24 hours |
| Sterilization | Entire product is sterile following exposure to
ethylene oxide (EO). | Hand tower is not sterile. The
U-scope 8000 HSC+EMB
cannula is sterile following
exposure to ethylene
oxide(EO). |
| Frequency of use | Disposable for a single usage | Hand tower is reusable. The |
| Attribute | Subject device | Predicative device |
| | | U-Scope 8000 Hsc+emb
Cannula |
| | | U-scope 8000 HSC+EMB
cannula is single patient use. |
| Tissue contact
material | Compliant with ISO 10993 | Compliant with ISO 10993 |
VI. Comparison of Technological Characteristics
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7
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The subjective device and predicative device have the same intended use. The subject and predicative device have different technological characteristics as evidenced by the table above. The differences in technological characteristics do not raise different questions of safety or effectiveness.
VII.Summary of non-clinical testing
The following performance data were provided to verify that the subject device met all design specifications. The results demonstrated that the subject device is as safe and effective as the predicate device..
- Risk Analysis developed in accordance with ISO 14971:2007.
- Electrical Safety Testing in accordance with IEC 60601-1:2005 (3rd Edition).
- The subject device was demonstrated to meet applicable sections of the standard.
- . Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014.
- The subject device was demonstrated to be electromagnetically compatible । in its intended environment of use.
- . Medical electrical equipment - Part 2-18: "Particular requirements for the basic essential performance of of endoscopic safety and a equipment" (IEC60601-2-18:2009).
- -The subject device met the requirements of the standard.
- . Biocompatibility Tests in accordance with ISO 10993, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010),irritation (ISO 10993-10:2010) and acute systemic toxicity (ISO 10993-11:2017).
- i The subject device was demonstrated to be non-cytotoxic, non-irritating, non-sensitizing, and not acutely toxic.
- Software Validation - Software Life Cycle Processes in accordance with IEC 62304:2015, and Guidance for Industry and FDA staff-Guidance for the content of premarket submissions for software contained in medical devices.Document issued on:May 11,2005.
- -The software of the subject device was demonstrated to function as intended per specification.
- Endoscopes-medical endoscopes and endotherapy devices-Part 1:General requirements-(ISO 8600-1:2015).
- The subject device was demonstrated to meet the requirements of the ।
9
standard.
- Optics and optical instruments - Medical endoscopes and endoscopic accessories —Part 3: Determination of field of view and direction of view of endoscopes with optics AMENDMENT 1.(ISO 8600-3:2003).
- The subject device was demonstrated to meet the requirements of the । standard.
- Endoscopes — Medical endoscopes and endotherapy devices —Part 4: Determination of maximum width of insertion portion.(ISO 8600-4:2014).
- The subject device was demonstrated to meet the requirements of the standard.
- Optics and photonics - Medical endoscopes and endotherapy devices -Part 5:Determination of optical resolution of rigid endoscopes with optics.(ISO 8600-5:2005).
- । The subject device was demonstrated to meet the requirements of the standard.
Due to its labeling as sterile, the Reedgyn disposable hysteroscope underwent sterilization validation and shelf life testing to confirm the label shelf life and was found in compliance with the following:
- Sterilization of health-care products - Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices. (ISO 11135:2014).
- . Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems. (ISO 11607-1:2006).
- . Standard guide for accelerated aging of sterile barrier systems for medical devices (ASTM F1980-16).
- . Sterilization of medical devices-Microbiological methods-Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process(ISO 11737-2:2009).
- Standard test method for determination of leaks in flexible packaging by bubble emission(ASTM D3078-02(2013)).
- . Standard test method for detecting seal leaks in porous medical packaging by dye penetration(ASTM F1929-15).
- . Sterilization-sterile supply -Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized(DIN 58953-6:2016).
- . Standard test method for seal strength of flexible barrier materials(ASTM F88/F88M-15).
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Results from testing demonstrate assurancethe device is sterile and remains sterile throughout the proposed shelf life.
VIII.Conclusion
The Reedgyn disposable hysteroscopes have similar indications to that of the predicate. The RH-2D-01 indications fall within those of the predicate, and the difference does not alter the intended use. The technological differences between Reedgyn disposable hysteroscopes and the predicate device do not raise different questions of safety and effectiveness. Performance testing as described above has demonstrated that the subject device is as safe and effective as the predicate device. Therefore, the subject device is substantially equivalent to the predicate device.