K Number

Device Name

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

Manufacturer

A & A MEDICAL, INC.

Date Cleared

1997-12-22

(60 days)

Product Code

HFC

Regulation Number

884.1050

Intended 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 Description

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

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K895403, K954102, K960263

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical suction for specimen collection and does not mention any computational or analytical capabilities that would involve AI/ML.

Therapeutic

No.
The device is used for specimen collection for diagnostic purposes (histological or cytological examination), not for treating a disease or condition.

Diagnostic

The device is a sampler for collecting specimens, not for diagnosing conditions. The collected specimens are sent to a laboratory for examination, which is where the diagnostic process occurs.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components (Plunger, O-ring, external tubing) and a mechanical action (pulling the plunger) for specimen collection, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Rocket Mucus Sampler is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The device is designed for the collection of specimens (cervical mucosal lining, etc.). It does not perform any diagnostic testing on the specimen itself. The specimen is collected and then sent to a laboratory to be examined.
Device Description: The description focuses on the mechanism for collecting the sample (suction, components). It does not describe any components or processes for analyzing the sample.
Lack of Diagnostic Function: The device's purpose is solely to obtain a sample for subsequent diagnostic testing performed elsewhere (in a laboratory).

IVD devices are those intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Rocket Mucus Sampler is a tool for obtaining the specimen, not for performing the in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

85 HFC

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cervical mucosal lining, external os, vaginal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Ob/Gyn physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K895403, K954102, K960263

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 884.1050 Endocervical aspirator.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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: (770) 343- 8400 4-Fax: (770) 343-8985

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:

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

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
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
Unimar. Inc.	K895403
web 510k	E	E	S	S	E	S	N/A	E	E	S	N/A	E	E	E	E	N/A
2- SelectMucus from
Select Medical Systems, Inc.	K954102
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
from Cook Urological. Inc.	K960263
web 510k
& summary	E	E	S	S	E	S	N/A	E	E	S	N/A	E	E	E	E	N/A

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.

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 (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

K974032 510(k) Number (if known):

Rocket Mucus Sampler Syringe Device Name:

Indications For Use:

(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)

ଠନ

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)