(25 days)
No
The summary describes a standard video hysteroscope and its accessories, focusing on its intended use for viewing and procedures. There is no mention of AI, ML, image processing beyond basic video capture, or any performance metrics typically associated with AI/ML algorithms (like sensitivity, specificity, AUC). The performance studies described are standard verification tests for a medical device, not studies evaluating AI/ML performance.
No
The device is described for "viewing... for the purpose of performing diagnostic and operative procedures," indicating its role as a tool during procedures rather than a therapeutic device itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended "for the purpose of performing diagnostic and operative procedures." This clearly indicates its use in diagnosing conditions.
No
The device description explicitly states that the device consists of an endoscope (a hysteroscope) which includes an insertion portion and handle, and accessories (valves and a silicone cap), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is a hysteroscope, which is an endoscope used for direct visualization of internal body cavities. This is a surgical/diagnostic instrument, not a device used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for direct visualization and procedures within the body.
N/A
Intended Use / Indications for Use
Single-Use Video Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.
The device is suitable for professional healthcare facility environments such as hospitals and clinics.
Product codes
HIH
Device Description
The subject device, Single-Use Video Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.
The device is suitable for professional healthcare facility environments such as hospitals and clinics.
The subject device consists of an endoscope (a hysteroscope) which includes an insertion portion and handle, and the following accessories: 2 pieces of two-way valves and 1 piece of silicone cap.
The subject Single-Use Video Hysteroscope is the same as the predicate Single-Use Video Hysteroscope (cleared under K232003) with respect to its indications for use, design, operating principle, and fundamental technology.
The subject device differs from the predicate device showed as below,
-
- All features of the new device (subject device) are identical to the predicate, with 2 accessories added to its primary package, consisting of 2 pieces of two-way valves and a silicone cap;
-
- The depth of field (DOF) of RP-G-C0101 is changed from 5 mm
50 mm to 3 mm50 mm.
- The depth of field (DOF) of RP-G-C0101 is changed from 5 mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical canal and uterine cavity
Indicated Patient Age Range
adult
Intended User / Care Setting
professional healthcare facility environments such as hospitals and clinics.
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)
As part of demonstrating substantial equivalence to the predicate, a risk analysis was completed to identify the risks associated with the design changes. Verification testing including performance testing using previously submitted methods and acceptance criteria cleared under K232003, additional biocompatibility testing per ISO 10993 standards, shelf life testing, and simulated transportation testing were conducted to evaluate the modifications. The subject device passed all the testing in accordance with internal requirements and applicable standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
August 2, 2024
Guangzhou Red Pine Medical Instrument Co., Ltd. Ping Yang Regulatory Affairs Manager 12 F, No.87 Luoxuan Avenue, Guangzhou International Bioisland, Huangpu District Guangzhou, Guangdong 510000 CHINA
Re: K241987
Trade/Device Name: Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: July 8, 2024 Received: July 8, 2024
Dear Ping Yang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
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,
Reginald K. Avery -S
for Jason R. Roberts, Ph.D. Assistant 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
3
Indications for Use
510(k) Number (if known) K241987
Device Name
Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
Indications for Use (Describe)
Single-Use Video Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.
The device is suitable for professional healthcare facility environments such as hospitals and clinics.
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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K241987 Page 1 / 4
510(k) SUMMARY
510(k) Number: K241987
I. Contact Details
Submitter Name: Guangzhou Red Pine Medical Instrument Co., Ltd.
Submitter Address: 12 F, No.87 Luoxuan Avenue, Guangzhou International Bioisland, Huangpu District Guangzhou Guangdong 510000 China
Submitter Contact Telephone: +86 13902971205
Submitter Contact: Mr. Weihua Yang
Submitter Contact Email: regulation(@gzredpine.com
Correspondent Name: Guangzhou Red Pine Medical Instrument Co., Ltd.
Correspondent Address: 12 F, No.87 Luoxuan Avenue, Guangzhou International Bioisland, Huangpu District Guangzhou Guangdong 510000 China
Correspondent Contact Telephone: +86 18565651640
Correspondent Contact: Mrs. Ping Yang
Correspondent Contact Email: regulation(@gzredpine.com
Date prepared: August 2, 2024
II. Subject Device
Device Trade Name: Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
Common Name: Hysteroscope and accessories
Classification Number: 21 CFR 884.1690
Classification Name: Hysteroscope and accessories
Product Code: HIH
III. Legally Marketed Predicate Device
Predicate 510(k) Number: K232003 Device name: Single-Use Video Hysteroscope: RP-G-C24, RP-G-C0101 Product Code: HIH Note: This predicate device has not been subject to a design-related recall.
5
IV. Device Description Summary
The subject device, Single-Use Video Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.
The device is suitable for professional healthcare facility environments such as hospitals and clinics.
The subject device consists of an endoscope (a hysteroscope) which includes an insertion portion and handle, and the following accessories: 2 pieces of two-way valves and 1 piece of silicone cap.
The subject Single-Use Video Hysteroscope is the same as the predicate Single-Use Video Hysteroscope (cleared under K232003) with respect to its indications for use, design, operating principle, and fundamental technology.
The subject device differs from the predicate device showed as below,
-
- All features of the new device (subject device) are identical to the predicate, with 2 accessories added to its primary package, consisting of 2 pieces of two-way valves and a silicone cap;
-
- The depth of field (DOF) of RP-G-C0101 is changed from 5 mm
50 mm to 3 mm50 mm.
- The depth of field (DOF) of RP-G-C0101 is changed from 5 mm
V. Indications for use
Single-Use Video Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.
The device is suitable for professional healthcare facility environments such as hospitals and clinics.
VI. Indications for Use Comparison
The subject device, Single-Use Video Hysteroscope, has the same indications for use in comparison to the predicate device, Single-Use Video Hysteroscope.
VII. Technological Comparison
The subject Single-Use Video Hysteroscope is the same as the predicate Single-Use Video Hysteroscope (cleared under K232003) with respect to its indications for use, design, operating principle, and fundamental technology.
The subject device differs from the predicate device showed as below,
-
- All features of the new device (subject device) are identical to the predicate, with 2 accessories added to its primary package, consisting of 2pcs of two-way valves and a silicone cap;
- The depth of field (DOF) of RP-G-C0101 is changed from 5 mm
50 mm into 3 mm50 mm. 2.
These differences between the subject and predicate device do not raise different questions of safety or effectiveness. As part of demonstrating substantial equivalence to the predicate, a risk analysis was completed to identify the risks associated with the above changes. Verification testing was conducted to evaluate the modifications. The subject device passed all testing in accordance with internal requirements and applicable standards to support substantial equivalence of the subject device.
VIII. Non-Clinical Tests Summary
As part of demonstrating substantial equivalence to the predicate, a risk analysis was completed to
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K241987 Page 3 / 4
identify the risks associated with the design changes. Verification testing including performance testing using previously submitted methods and acceptance criteria cleared under K232003, additional biocompatibility testing per ISO 10993 standards, shelf life testing, and simulated transportation testing were conducted to evaluate the modifications. The subject device passed all the testing in accordance with internal requirements and applicable standards.
A Biocompatibility Summary
The biocompatibility evaluation for the patient contacting components was conducted in accordance with the 2023 FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The following testing was conducted based on contact category of "Surface – Breached or Compromised Surface" with a contact duration of "Limited (
A Sterilization Validation
The subject device is sterilized via ethylene oxide (EO). The sterilization method has been validated to ISO 11135:2014 half-cycle method, which has thereby determined the routine control and monitoring parameters.
EO/ethylene chlorohydrin (ECH) residual testing was performed according to ISO 10993-7:2008 and was below the stated residual limits.
A Shelf Life and simulated transportation distribution followed by sterile packaging integrity test
Shelf Life and simulated transportation distribution followed by packaging integrity testing have been validated according to the following applicable standards:
- ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ISO 11607-1:2019 Packaging for terminally sterilized Medical Device Part 1: Requirement for materials, sterile barrier systems and packaging systems
- ISO 11607-2:2019 Packaging for terminally sterilized Medical Device Part 2: Validation Requirement for forming, sealing and assembly process
- ASTM F 1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- | ASTM F88/F88M-23 Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- ASTM D4169-23 Standard Practice for Performance Testing of Shipping Containers and Systems
7
> Performance
The following performance testing was conducted using previously submitted methods and acceptance criteria cleared under K232003 in support of the substantial equivalence, as shown in the table below.
| Test category | Test Item |
|---|---|
| Mechanical | |
| performance | Surface and Edges Visual Assessment |
| Water Delivery System (Flow Rate and Leakage Testing) | |
| Basic Size (Dimensional Analysis and Compatibility Testing of the | |
| Two-way Valve) | |
| Comprehensive Performance of Luer Taper per ISO 80369-7:2021 | |
| and ISO 80369-20:2015 | |
| Pullout Force of Silicone Cap | |
| Compatibility with Accessories When Installing Silicone Cap | |
| Sealing Test after Installing the Two-way Valve (Leakage Testing | |
| under Pressure) | |
| Optical | |
| performance | Depth of field |
IX. Clinical Evidence
N/A.
X. Conclusion
The results of nonclinical performance testing demonstrate that the subject device is as safe and effective as the predicate device to support a substantial equivalence determination.