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.

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.

AI/ML Overview

The provided document, K241987, describes a 510(k) premarket notification for a medical device and does not contain information about acceptance criteria and a study that proves the device meets those criteria from an AI/algorithm performance perspective.

The document is a K241987 submission for a Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101). This device is a traditional medical instrument used for viewing the cervical canal and uterine cavity. It is not an AI/algorithm-based device.

Therefore, many of the requested fields related to AI/algorithm performance, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this submission.

The "Performance" section within the document refers to non-clinical performance testing of the physical device, such as mechanical, optical, and biocompatibility tests, not an algorithm's performance.

Here's a breakdown of the information that is available in the document, framed against your request:

Acceptance Criteria and Device Performance for Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)

As this is a physical medical device (a hysteroscope) and not an AI or algorithm, the acceptance criteria and performance data relate to its physical and functional attributes. The document states that "Verification testing including performance testing using previously submitted methods and acceptance criteria cleared under K232003... were conducted to evaluate the modifications. The subject device passed all the testing in accordance with internal requirements and applicable standards."

Due to the nature of the device, many of the requested fields are not relevant.

1. A table of acceptance criteria and the reported device performance

The document lists performance tests conducted but does not explicitly detail the quantitative acceptance criteria or the specific reported device performance values beyond stating that the "subject device passed all the testing." The acceptance criteria are implicitly those established for the predicate device (K232003) and internal requirements/applicable standards.

Test category	Test Item	Acceptance Criteria (from K232003 / applicable standards)	Reported Device Performance
Mechanical Performance	Surface and Edges Visual Assessment	Passed	Passed
	Water Delivery System (Flow Rate and Leakage Testing)	Passed	Passed
	Basic Size (Dimensional Analysis and Compatibility Testing of the Two-way Valve)	Passed	Passed
	Comprehensive Performance of Luer Taper per ISO 80369-7:2021 and ISO 80369-20:2015	Passed	Passed
	Pullout Force of Silicone Cap	Passed	Passed
	Compatibility with Accessories When Installing Silicone Cap	Passed	Passed
	Sealing Test after Installing the Two-way Valve (Leakage Testing under Pressure)	Passed	Passed
Optical Performance	Depth of field (Note: RP-G-C0101 changed from 5 mm~~50 mm to 3 mm~~50 mm, which implies this new range is the acceptance criteria for the modified device).	3 mm ~ 50 mm (for RP-G-C0101)	Met
Biocompatibility	Cytotoxicity test per ISO 10993-5:2009	Passed	Passed
	Sensitization test per ISO 10993-10:2011	Passed	Passed
	Intracutaneous Reactivity test per ISO 10993-23:2021	Passed	Passed
	Acute Systemic Toxicity test per ISO 10993-11:2017	Passed	Passed
	Material-Mediated Pyrogenicity test per USP <151>	Passed	Passed
Sterilization	EO/ethylene chlorohydrin (ECH) residual testing per ISO 10993-7:2008	Below stated residual limits	Met
Shelf Life & Packaging	ASTM F1980-21, ISO 11607-1:2019, ISO 11607-2:2019, ASTM F 1929-15, ASTM F88/F88M-23, ASTM F1886/F1886M-16, ASTM D4169-23	Passed	Passed

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for individual performance tests. The testing refers to "subject device" and implies a representative number of units were tested.
Data Provenance: Not specified. Testing was conducted internally by Guangzhou Red Pine Medical Instrument Co., Ltd.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This relates to human expert review for AI/algorithm performance. The device is a physical hysteroscope. The "truth" for physical performance tests (e.g., leakage, dimensions, biocompatibility) is determined by objective measurements against established standards, not expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical device, not an AI system. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For Biocompatibility: "Ground truth" is established by adherence to recognized international standards (e.g., ISO 10993 series, USP <151>) and observable biological responses in tests.
For Mechanical/Optical Performance: "Ground truth" is based on engineer specifications, physical measurements, and conformity to applicable industry standards (e.g., ISO 80369-7:2021).
For Sterilization/Shelf Life: "Ground truth" is based on validated methods (e.g., ISO 11135:2014) demonstrating sterility assurance levels and packaging integrity per standards (e.g., ISO 11607).

8. The sample size for the training set

Not applicable. This device does not involve a training set as it's not an AI/algorithm-based device.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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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"

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(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

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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

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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.

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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,

1. 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;
1. The depth of field (DOF) of RP-G-C0101 is changed from 5 mm~~50 mm to 3 mm~~50 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 device differs from the predicate device showed as below,

1. 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 mm~~50 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 (< 24 hours)":

Cytotoxicity test per ISO 10993-5:2009
Sensitization test per ISO 10993-10:2011
Intracutaneous Reactivity test per ISO 10993-23:2021
Acute Systemic Toxicity test per ISO 10993-11:2017
Material-Mediated Pyrogenicity test per USP <151>

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

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> 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
Mechanicalperformance	Surface and Edges Visual Assessment
	Water Delivery System (Flow Rate and Leakage Testing)
	Basic Size (Dimensional Analysis and Compatibility Testing of theTwo-way Valve)
	Comprehensive Performance of Luer Taper per ISO 80369-7:2021and 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 Testingunder Pressure)
Opticalperformance	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.

Regulation Number and Section

§ 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.