ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR

K974032 · A & A Medical, Inc. · HFC · Dec 22, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K974032
• Device Name: ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR
• Applicant: A & A Medical, Inc.
• Product Code: HFC · Obstetrics/Gynecology
• Decision Date: Dec 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1050
• Device Class: Class 2

Indications for Use

The Rocket Mucus Sampler is designed for optimum suction for the collection of cervical mucosal lining, post coital test (Huhner), external os or vaginal pool sampling. The Rocket Mucous Sampler enables the Ob/Gyn physician to collect the specimen and send it to the laboratory to be examined histologically or cytologically

Device Story

Rocket Mucus Sampler Syringe is a manual aspiration device used by Ob/Gyn physicians in clinical settings. It consists of a plunger, O-ring, and external tubing (2.6mm OD). Operation involves manual retraction of the plunger to create suction, allowing for the collection of cervical mucosal lining, post-coital test samples, or vaginal pool specimens. The collected specimen is then sent to a laboratory for histological or cytological analysis. The device design aims to minimize patient discomfort during collection.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Manual suction syringe; 2.6mm outer diameter tubing; plunger and O-ring assembly. Non-powered, manual operation. Sterility and biocompatibility characteristics are equivalent to predicate devices.

Indications for Use

Indicated for Ob/Gyn physicians to collect cervical mucosal lining, post-coital (Huhner) test specimens, external os, or vaginal pool samples for histological or cytological laboratory examination.

Regulatory Classification

Identification

An endocervical aspirator is a device designed to remove tissue from the endocervix (mucous membrane lining the canal of the cervix of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to evaluate endocervical tissue to detect malignant and premalignant lesions.

Predicate Devices

• Aspirette Endocervical Aspirator (K895403)
• SelectMucus (K954102)
• Cervical Mucous Aspiration Catheter (K960263)

Submission Summary (Full Text)

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K974032

P1093

DEC 22 1997

# 510(k) Summary As Required by 21 section 807.92 ( c )

A & A Medical, Inc. 1-Submitter Name:

4100 Nine McFarland Drive, suite B 2-Address:

Alpharetta, GA 30004

3-Phone: [phone]-Fax: [phone]

5-Contact Person: Jihad Mansour

6-Date summary prepared: October 22nd, 1997

7-Device Trade or Proprietary Name: Mucus Sampler Syringe

8-Device Common or usual name: Mucus Sampler Syringe

Endocervical Aspirator 9-Device Classification Name:

10-Substantial Equivalency is claimed against the following devices:

1-Aspirette Endocervical Aspirator from Unimar, Inc. 2-SelectMucus from Select Medical Systems, Inc 3-Cervical Mucous Aspiration Catheter from Cook Urological, Inc

#### 11-Description of the Device:

The Rocket Mucus Sampler is designed for optimum suction for the collection of cervical mucosal lining, post coital test (Huhner), external os or vaginal pool sampling. It is comprised of 3 components: Plunger, O-ring and external tubing. Suction is created by pulling the plunger with a handle outward.

It has a small OD of 2.6mm, which minimizes pain and discomfort to the patient. The Rocket Mucous Sampler enables the Ob/Gyn physician to collect the specimen and send it to the laboratory to be examined histologically or cytologically

#### 12-Intended use of the device: (ALSO PRINTED SEPARATELY ON FDA FORM)

The Rocket Mucus Sampler is designed for optimum suction for the collection of cervical mucosal lining, post coital test (Huhner), external os or vaginal pool sampling. The Rocket Mucous Sampler enables the Ob/Gyn physician to collect the specimen and send it to the laboratory to be examined histologically or cytologically

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K974032

P203

### 13-Safety and Effectiveness of the device:

Rocket Mucus Sampler Syringe is as safe and effective as other predicate devices cited above.

This is better expressed in the tabulated comparison ( Paragraph 14 below )

## 14-Summary comparing technological characteristics with other predicate devices:

Please find below a tabulated comparison supporting that Rocket Mucus Sampler is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached

P.S. Abbreviations used below: E=Equivalent, S=Similar, D=Different, N/A= Not Applicable, DES-Description available, N/I=No Information available, 510(k)Summary available, 510(k)=510(k) available, web=fda web printout enclosed

| | TECHNOLOGICAL CHARACTERISTICS | | | | | | | | | | | | | | | | |
|----------------------------------------------------------------------|--------------------------------------------------------------|---------------------|-------------------|--------|-----------|-------------|-----------|------------------|-------------------|-----------------|------------------|---------------|------------------------------|----------------------------------------------|------------|---------------|-------------------|
| | FDA file reference number<br>Attachments inside Notification | Indications for use | Target population | Design | Materials | Performance | Sterility | Biocompatibility | Mechanical Safety | Chemical Safety | Anatomical sites | Human Factors | Energy used and/or delivered | Compatibility w/ environment & other devices | Where used | Standards met | Electrical Safety |
| 1- Aspirette Endocervical Aspirator from<br>Unimar. Inc. | k895403<br>web 510k | E | E | S | S | E | S | N/A | E | E | S | N/A | E | E | E | E | N/A |
| 2- SelectMucus from<br>Select Medical Systems, Inc. | k954102<br>web 510k | E | E | S | S | E | S | N/A | E | E | S | N/A | E | E | E | E | N/A |
| 3- Cervical Mucous Aspiration Catheter<br>from Cook Urological. Inc. | k960263<br>web 510k<br>& summary | E | E | S | S | E | S | N/A | E | E | S | N/A | E | E | E | E | N/A |

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Image /page/2/Figure/2 description: The image shows a sequence of alphanumeric characters, specifically 'K974032'. The characters are written in a simple, slightly rough font, giving them a handwritten or printed appearance. The numbers and letters are evenly spaced and horizontally aligned.

8 30 3 ENT I ATTACHI

# tial Equival ence" Process I

Image /page/2/Figure/5 description: This image is a flowchart that outlines the process for determining if a new device is substantially equivalent to a marketed device. The flowchart starts with the question of whether the new device has the same intended use as the marketed device. If the answer is no, the determination is "Not Substantial". If the answer is yes, the flowchart proceeds to the next question of whether the new device has technological characteristics that raise new types of safety or effectiveness questions. The flowchart ends with a determination of "Substantial Equivalent" if all the questions are answered positively.

A more Detailed version is also available in pdf version or found directly below.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 1997

Mr. Jihad Mansour Quality Assurance & Regulatory Affairs Manager A & A Medical, Inc. Nine McFarland Drive, Suite B Alpharetta, Georgia 30004-3386

DEPARTMENT OF HEALTH & HUMAN SERVICES

K974032 Re: Rocket Mucus Sampler Syringe Dated: October 22, 1997 Received: October 23, 1997 Regulatory class: II 21 CFR §884.1050/Product code: 85 HFC

Dear Mr. Mansour:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, 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.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K974032 510(k) Number (if known):

Rocket Mucus Sampler Syringe Device Name:

Indications For Use:

The Rocket Mucus Sampler is designed for optimum suction for the collection of cervical mucosal lining, post coital test (Huhner), external os or vaginal pool sampling. The Rocket Mucous Sampler enables the Ob/Gyn physician to collect the specimen and send it to the laboratory to be examined histologically or cytologically

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Roder D. Satherg
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K974032

Prescription Use V (Per 21 CFR 801.109)

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)