The Disposable Endometrial Suction Curette is indicated for obtaining endometrial tissue samples by vacuum suction for endometrial histopathology examination. The specimens obtained are then used for the following: Endometrial cancer detection, Determine response to estrogen replacement therapy, Detection of pathology resulting in: Infertility, menstrual disorders, abnormal or dysfunctional uterine bleeding, postmenopausal bleeding, endometrial dating.

Device Description

The proposed device is single-use, sterile disposable endometrial suction curette, which is intended to obtain endometrial tissue samples by vacuum suction mainly for endometrial histopathology examination and cytological examination or clinical examination in Gynaecological examination. Disposable Endometrial Suction Curette, including Type A and Type B, consists of a rod, barrel ' and sealing ring. The rod is used to generate negative pressure to draw the sample (fluid or mucous) into the barrel. The barrel is used to contain the drawn samples. The sealing ring ensures that the handle can be assembled closed with the barrel for keeping certain negative pressure.

AI/ML Overview

The provided text describes a 510(k) summary for a Disposable Endometrial Suction Curette (K102847). This submission is for a medical device that obtains tissue samples, and the regulatory review focuses on substantial equivalence to a predicate device rather than novel performance claims. As such, the information you're requesting regarding acceptance criteria from clinical studies as typically understood for AI/diagnostic algorithms is largely not applicable in this context.

Here's an explanation based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance	Comments
Safety and Efficacy (General)	"sufficient to ensure the efficacy and safety of the device for its intended use"	Device determined to be "substantially equivalent" to predicate based on these tests.	This is a blanket statement for the entire submission, not specific, quantifiable performance metrics for a diagnostic algorithm. The "efficacy" here refers to the device's ability to mechanically perform its function, not diagnostic accuracy.
Physical Characteristics	Visual Inspection	Pass (implied by substantial equivalence)	Ensures product meets aesthetic and basic presentation standards.
Dimensional Specifications	Dimensional Tests	Pass (implied by substantial equivalence)	Confirms the physical dimensions of the device are as designed and comparable to the predicate.
Functional Performance	Functional Tests	Pass (implied by substantial equivalence)	The device must demonstrably perform its core function (e.g., generate negative pressure to draw samples). The text does not detail the specific functional tests or their results, but states they were developed and deemed sufficient.
Biocompatibility (Implied)	(Not explicitly stated in provided text, but generally required for medical devices coming into contact with human tissue)	Pass (implied by substantial equivalence to a legally marketed device)	This would involve tests to ensure the materials are non-toxic and do not cause adverse reactions.
Sterility (Implied)	(Not explicitly stated, but crucial for single-use devices intended for internal use)	Pass (implied by the description "sterile disposable")	Tests to ensure the device is free of microorganisms.
Packaging & Labeling (Implied)	(Not explicitly stated, but part of regulatory review)	Pass (implied by FDA clearance)	Ensuring correct labeling, instructions for use, and protection during transit.

Important Note: The provided text does not include any acceptance criteria related to diagnostic accuracy, sensitivity, or specificity by comparing device output to a ground truth, which would typically be present for an AI-powered diagnostic device. This is because the device itself is a sampling tool, not a diagnostic algorithm. Its "performance" is about its ability to obtain a sample, not to interpret it.

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 for Test Set: Not applicable. The "tests" mentioned are primarily engineering and functional tests of the physical device, not clinical studies involving a patient test set in the way an AI diagnostic would have. No patient data or clinical samples are described as being used for the purpose of determining performance for this 510(k) submission.
Data Provenance: Not applicable.

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):

Number of Experts/Qualifications: Not applicable. There was no clinical ground truth established for a test set in the context of this device's performance evaluation for the 510(k) submission. The "ground truth" for the device's function would be its ability to physically collect a sample, which is assessed through engineering tests.

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

Adjudication Method: Not applicable. No clinical test set or subjective interpretations requiring adjudication were involved.

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:

MRMC Study: No. This device is a physical sampling tool, not an AI or diagnostic algorithm that would assist human readers in interpretation. Therefore, an MRMC study is not relevant.

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

Standalone Performance: No. This is a physical medical device, not an algorithm.

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

Type of Ground Truth: Not applicable in the context of diagnostic performance. The "ground truth" for this device's function would be the successful collection of endometrial tissue, which is assessed through its mechanical and functional tests. The subsequent diagnostic examination of the collected specimen (e.g., for cancer) would use pathology as ground truth, but that is a downstream process performed by a lab, not part of this device's performance evaluation.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.

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

Ground Truth for Training Set: Not applicable.

Summary of the Study (as described for this device):

The "study" described for the Disposable Endometrial Suction Curette (K102847) is a non-clinical performance evaluation focused on engineering and functional testing, rather than a clinical trial measuring diagnostic accuracy.

Purpose: To demonstrate that the proposed device is substantially equivalent to a legally marketed predicate device (SelectCells™Mini, K974819).
Methodology:
- "Tests have been developed which are considered sufficient to ensure the efficacy and safety of the device for its intended use."
- These tests included:
  - Visual inspection: To confirm the device's physical appearance and integrity.
  - Dimensional checks: To ensure the device conforms to design specifications.
  - Functional tests: To verify that the device can perform its intended mechanical action (e.g., generating negative pressure to aspirate samples).
Key Finding: Based on these tests, the device was determined to be "substantially equivalent" to the predicate device. This means the FDA found that the new device is as safe and effective as the predicate device already on the market, despite not explicitly detailing all test results. The 510(k) process primarily relies on demonstrating equivalence rather than proving novel efficacy.

In essence, this submission is for a physical instrument, and its "performance" means it works as intended mechanically to collect a sample, not that it interprets diagnostic information. Therefore, the types of detailed acceptance criteria, ground truth, and studies typically associated with AI/diagnostic algorithms are not documented in this 510(k) summary.

Summary

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Exhibit #1 510(k) Summary APR 1 4 2011

Disposable Endometrial Suction Curette As required by 21 CFR 807.92(k)

The assigned 510(k) Number is: K102847

1 . Date Prepared: September 27, 2010

Sponsor Information

Jiangsu Suyun Medical Materials Co., Ltd No.18, Jinqiao Road, Dapu Industrial Park, Lianyungang Economic Development Zone, Lianyungang, Jiangsu, 222000, China Establishment Registration Number: 9680254

Contact Person: Mr. Guangning Xu, Quality Manager Tel: +86-0518-85608151 Fax: +86-0518-85466033 E-Mail: quality@suyunmedical.com

Submission Correspondent 3.

Ms. Diana Hong, Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. BOX 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

Proposed Device

Device Trade Name: Disposable Endometrial Suction Curette Model: Type A and Type B Device Classification Name: Curette, Suction, Endometrial (And Accessories) Product Code: HHK Regulation Number: 21 CFR 884.1175 Device Class: II Review Panel: Obstetrics/Gynecology

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Premarket Notification Traditional Section 510(k) Submission --Exhibit #1 510(k) Summary

Intended Use:

The Disposable Endometrial Suction Curette is indicated for obtaining endometrial tissue samples by vacuum suction for endometrial histopathology examination.

The specimens obtained are then used for the following:

. Endometrial cancer detection
Determine response to estrogen replacement therapy
Detection of pathology resulting in: .
- Infertility
- menstrual disorders
- abnormal or dysfunctional uterine bleeding ،
- postmenopausal bleeding
endometrial dating
న్. Predicate Device Identification:

510(k) Number: K974819 Trade/Proprietary Name: SelectCells™Mini Submitter: Select Medical Systems, Inc Classification Name: Curette, Suction, Endometrial (And Accessories)

Intended Use:

The SelectCells™Mini is s single use, sterile, disposable endometrial sampling device designed to be used for obtaining a histologic biopsy of the uterine mucosal lining or specimen of the uterine menstrual content.

The specimen obtained is then used for the following:

evaluation of infertility conditions, menstrual disorders, postmenopausal bleeding, abnormal (i) cytology suspected of being of endometrial origin, hormonal replacement therapy;
detection of endometrial carcinoma; (ii)
(iii) diagnosis of luteal defect;
(iv) endometrial dating and.
microscopic examination. (v)

6. Device Description:

Disposable Endometrial Suction Curette, including Type A and Type B, consists of a rod, barrel ' and sealing ring. The rod is used to generate negative pressure to draw the sample (fluid or

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mucous) into the barrel. The barrel is used to contain the drawn samples. The sealing ring ensures that the handle can be assembled closed with the barrel for keeping certain negative pressure.

K102847

7. Test Conclusion

There is no published standards for these particular types of products, and as such tests have been developed which are considered sufficient to ensure the efficacy and safety of the device for its intended use. Such tests include -- Visual; Dimensional; and Functional,

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Substantially Equivalent Conclusion 8.

The proposed device, Disposable Endometrial Suction Curette, has been tested and compared to predicate device, and it is determined to be substantially equivalent to the predicate device.

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Image /page/4/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the edge. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Jiangsu Suyun Medical Materials Co., Ltd. c/o Ms. Diana Hong Submission Correspondent Mid-Link Consulting Co., Ltd. P.O. Box 237-023 SHANGHAI 200237 CHINA

APR 1 4 2011

Re: K102847

Trade Name: Disposable Endometrial Suction Curette Regulation Number: 21 CFR §884.1175 Regulation Name: Endometrial suction curette and accessories Regulatory Class: II Product Code: HHK Dated: March 14, 2011 Received: March 16, 2011

Dear Ms. Hong:

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 of medical device-related

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Hubert Lehman MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit #2 Indication for Use Form

510(k) Number: K10284 Device Name: Disposable Endometrial Suction Curette

Indications for Use:

The Disposable Endometrial Suction Curette is indicated for obtaining endometrial tissue samples by vacuum suction for endometrial histopathology examination.

The specimens obtained are then used for the following:

Endometrial cancer detection
Determine response to estrogen replacement therapy
. Detection of pathology resulting in:
- Infertility -
- . menstrual disorders
- abnormal or dysfunctional uterine bleeding -
- postmenopausal bleeding
Endometrial dating .

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

how m Whan

Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K102847

2-1

Regulation Number and Section

§ 884.1175 Endometrial suction curette and accessories.

(a)
Identification. An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.(b)
Classification. Class II (performance standards).