ENDOMETRIAL SAMPLING SYRINGE

K040189 · Rocket Medical Plc · HHK · Oct 4, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K040189
• Device Name: ENDOMETRIAL SAMPLING SYRINGE
• Applicant: Rocket Medical Plc
• Product Code: HHK · Obstetrics/Gynecology
• Decision Date: Oct 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1175
• Device Class: Class 2

Indications for Use

The Endometrial Sampling Syringe can be used for a variety of clinical conditions which could include the following: For histological biopsy of the endometrium & endo-cervix in post menopausal screening. Hormone therapy monitoring. Endometrial dating. Detection of endometrial carcinoma. Bacterial culturing.

Device Story

The Embryon Endometrial Sampling Syringe is a manual suction device used by clinicians for uterine tissue sampling. It consists of a polypropylene sheath and an internal piston/cannula mechanism. The device is inserted into the uterine cavity; the clinician operates the piston to create suction, drawing tissue through a distal sampling hole into the cannula. The device facilitates histological biopsy, endometrial dating, and bacterial culturing. It is a single-use, manual instrument designed for clinical settings. No electronic, software, or AI components are involved.

Clinical Evidence

No clinical data. The device was evaluated via laboratory performance testing comparing the subject device to the predicate product.

Technological Characteristics

Manual endometrial suction curette. Materials: Polypropylene sheath. Principle: Mechanical suction via piston-cannula mechanism. Dimensions: 3.1mm outer diameter, 26mm length (sheath). No energy source, no software, no connectivity.

Indications for Use

Indicated for histological biopsy of the endometrium and endo-cervix in post-menopausal women, hormone therapy monitoring, endometrial dating, detection of endometrial carcinoma, and bacterial culturing.

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

• Unimar Endometrial Pipelle (K854415)

Submission Summary (Full Text)

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# Rocket Medical plc - 510(k) Notification Endometrial Sampling Syringe

# Summary of Safety and Effectiveness

JE: 5 = 2004

eplaced

S2

K040189
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Common or usual name: Classification name:

Endometrial Sampling Syringe Endometrial Suction Curette & Accessories CFR# 884.1175 Class II

This device is being designed to allow the safe and effective the histologic biopsy of the This device is being designed to ancyost menopausal screening and hormone therapy endomethum "and" endometrial carcinoma, endometrial dating and bacterial culturing.

This is achieved by a design where the slim form of the sampling syringe makes in most This is actieved by a dealer which as a polypropylene sheath permitting easy entry into the uterine cavity.

The sheath / cannula mechanism gives good suction and when combined with the shape and form of the curette opening gives good sample extraction.

This is a class II device, registered by Rocket Medical (Establishment number: 8010022/9610632). This device is substantially equivalent to a medical device which is 8010022. For 0032). "This been submitted to the FDA, marketed by Unimar Inc, 475 Currently in commore and has over on only of the name: Endometrial Pipelle.

The device we believe is safe and effective for the application for which it is intended having The device we believe is baie anwaluation. The device has yet to be clinically evaluated but been subjected to a real laboratory performance testing against competitor product.

Rocket Medical will continue to searcy all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety sancey and effectiveness information and as such, applicable data will be recorded for this product.

### CERTIFICATION

I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.

| 15. 5. 2004 | T. Charlton |
|--------------------------|----------------------------------------------------|
| Date | Signed by Tracy Charlton |
| | Regulatory Affairs Manager |
| | Rocket Medical plc |
| | Wear Industrial Estate, Washington |
| | Tyne & Wear, England. NE38 9BZ |
| Contact Person/Submitter | Mr Richard Keen |
| | Compliance Consultants |
| | 1151 Hope Street, Stamford, Connecticut 06907, USA |
| | Tel: [phone] Fax: [phone] |

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| ubstantial Equivalence | | |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| | Rocket Endometrial Sampling Syringe | Unimar Endometrial Pipelle |
| Outer Sheath | Overall Length 26mm<br>Outer diameter 3.1 od<br>Inner diameter --<br>Graduations 6-14cm | 265mm<br>3.1 od<br>2.6 id<br>4-10cm |
| Sampling Hole | Size 2mm<br>Bevel angle Perpendicular punch<br>Location 5mm from distal end | 2.4mm<br>Perpendicular punch<br>8mm from distal end |
| Inner Piston (Cannula) | Initial position relative to<br>sampling hole 233mm 225mm | |
| Assembled device | Flexural properties Rocket Medical's Endometrial Sampling Syringe is comparible with the Unimar Endometrial<br>Pipelle in dimensional sizes, look and material as per the above dimensions etc. We believe this is<br>proof with regard to the flexural properties and also likeness of a similar product on the current<br>US market. | |
| | Equivalent to: Unimar Inc, 475 Danbury Road, Wilton, CT 06897, 510(k) Number K854415.<br>Device name: Endometrial Pipelle. | |

Question 6

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Appendix A

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K040189
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is facing to the right. The logo is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 4 - 2004

Rocket Medical PLC ්% Mr. Richard Keen Compliance Consultants 1151 Hope Street STAMFORD CT 06907 Re: K040189 Trade/Device Name: Embryon® Endometrial Sampling Syringe Regulation Number: 21 CFR 884.1175 Regulation Name: Endometrial suction curette and accessories

Regulatory Class: II Product Code: 85 HHK Dated: July 16, 2004 Received: July 26, 2004

Dear Mr. Keen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have revewed your Section 710(ts) prematically equivalent (for the indications for use stated in above and have decemined the de nee icate devices marketed in interstate commerce prior to the enclosure) to regally mankeled predical Device Amendments, or to devices that have been May 26, 1970, the elacinent date of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordatics with the provisions of application (PMA). You may, therefore, market the do not require approval of a premance approvisions of the Act. The general controls provisions of the Act. device, subject to the general controls providenties, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classified (see ao ro) miss and controls. Existing major regulations affecting your Apploval), it may oc subject to sactrademons, 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 Please be advised mat 1 D/P 3 155dailed of acvice complies with other requirements of the Act of any FDA has made a decemination mad your active rederal agencies. You must comply with all the Federal statues and regulations administered of only - entitle - end 807); labeling Act s requirements, metuding, but not minted to regulations as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manceing your ence of your device of your device to a legally premarket nothcation. The I DA Inding of backannal report device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Pat 801), please If you desire specific advice for your device of our the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation enation on your responsibilities under the Act from the 807.97). Tou may outlin other general mistiance and Consumer Assistance at its toll-free number (800) DWNslon of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmam.html

Singerely yours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K040189

Embryon® Endometrial Sampling Syringe Device Name:

Indications for Use:

The Endometrial Sampling Syringe can be used for a variety of clinical conditions which could include the following:

- For histological biopsy of the endometrium & endo-cervix in post menopausal screening. .
- Hormone therapy monitoring. .
- Endometrial dating .
- Detection of endometrial carcinoma .
- Bacterial culturing .

Prescription Use (Part 21 CFR 801 Subpart D)

and / or

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

David A. Logman

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Dev 510(k) Number