DISPOSABLE ENDOMETRIAL SUCTION CURETTE

K102847 · Jiangsu Suyun Medical Materials Co., Ltd. · HHK · Apr 14, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K102847
• Device Name: DISPOSABLE ENDOMETRIAL SUCTION CURETTE
• Applicant: Jiangsu Suyun Medical Materials Co., Ltd.
• Product Code: HHK · Obstetrics/Gynecology
• Decision Date: Apr 14, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1175
• Device Class: Class 2

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

Device Story

Disposable manual suction curette (Type A and Type B) used to obtain endometrial tissue samples. Device consists of a rod, barrel, and sealing ring. Operator (clinician) manually manipulates rod to generate negative pressure, drawing tissue/fluid samples into the barrel for histopathological examination. Used in clinical/gynecological settings. Provides tissue specimens for diagnosis of endometrial cancer, infertility, menstrual disorders, and monitoring of hormone replacement therapy. Benefits patient by enabling minimally invasive, office-based tissue sampling for diagnostic evaluation.

Clinical Evidence

Bench testing only. No clinical data provided. Efficacy and safety were established through visual, dimensional, and functional testing.

Technological Characteristics

Manual suction curette consisting of a rod, barrel, and sealing ring. Single-use, sterile. Operates via manual generation of negative pressure. No energy source. No software or electronic components.

Indications for Use

Indicated for obtaining endometrial tissue samples via vacuum suction for histopathology in patients requiring evaluation for endometrial cancer, response to estrogen replacement therapy, infertility, menstrual disorders, abnormal/dysfunctional uterine bleeding, postmenopausal bleeding, or endometrial dating.

Regulatory Classification

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.

Predicate Devices

• SelectCells™Mini (K974819)

Submission Summary (Full Text)

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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

2. 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: [phone] Fax: [phone] E-Mail: [e-mail]

#### Submission Correspondent 3.

Ms. Diana Hong, Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. BOX 237-023, Shanghai, 200237, China Tel: [phone] Fax: [phone] Email: [e-mail]

4. 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:

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

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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 [phone] or [phone] 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)

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how m Whan

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

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