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

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "Rocket Mucus Sampler Syringe." It claims substantial equivalence to existing predicate devices, rather than presenting a study demonstrating the device meets specific acceptance criteria based on performance outcomes. Therefore, much of the requested information regarding acceptance criteria and a study to prove performance is not available in this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or functional thresholds). Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices.

The table provided (paragraph 14) compares technological characteristics of the Rocket Mucus Sampler with three predicate devices:

Technological Characteristic	Rocket Mucus Sampler vs. Predicate Devices (Summary)
Indications for Use	Equivalent (E)
Target population	Equivalent (E)
Design	Similar (S)
Materials	Similar (S)
Performance	Equivalent (E)
Sterility	Similar (S)
Biocompatibility	Not applicable (N/A) / No information (N/I)
Mechanical Safety	Equivalent (E)
Chemical Safety	Equivalent (E)
Anatomical sites	Similar (S)
Human Factors	Not applicable (N/A)
Energy used and/or delivered	Equivalent (E)
Compatibility w/ environment & devices	Equivalent (E)
Where used	Equivalent (E)
Standards met	Equivalent (E)
Electrical Safety	Not applicable (N/A)

Interpretation: The "Performance: Equivalent (E)" entry in the table is the closest to an "acceptance criterion," implying that the Rocket Mucus Sampler is expected to perform at a level comparable to the predicate devices for its intended use, which is optimal suction for the collection of cervical mucosal lining, post coital test (Huhner), external os or vaginal pool sampling. However, no specific metrics or thresholds are provided for this "performance."

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The document does not describe a performance study with a test set. The 510(k) submission is based on demonstrating substantial equivalence to existing devices through a comparison of technological characteristics, not through new clinical or performance data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No test set or ground truth derived from expert consensus is mentioned in the document.

4. Adjudication Method for the Test Set

Not applicable. No test set adjudication method is described.

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

Not applicable. This device is a physical medical instrument (a mucus sampler syringe), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study involving human readers and AI is not relevant to this submission.

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

Not applicable. This is not an algorithmic device.

7. The type of ground truth used

Not applicable. The submission relies on demonstrating substantial equivalence to predicate devices already on the market, rather than establishing a new ground truth based on pathology, outcomes data, or expert consensus from a new study. The "ground truth" here is the established safety and effectiveness of the existing predicate devices.

8. The sample size for the training set

Not applicable. This is not an algorithmic device that requires a training set.

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

Not applicable. No training set is described.

Summary of 510(k) Approach:

The K974032 submission for the Rocket Mucus Sampler Syringe is a 510(k) premarket notification which primarily relies on demonstrating substantial equivalence to legally marketed predicate devices. This means the manufacturer asserts that their new device is as safe and effective as, and has the same intended use and similar technological characteristics to, a legally marketed device that does not require premarket approval (PMA).

The "study" in this context is the comparison of technological characteristics against the predicate devices (Aspirette Endocervical Aspirator, SelectMucus, and Cervical Mucous Aspiration Catheter). The acceptance "criteria" are implicitly met if the FDA agrees that the Rocket Mucus Sampler Syringe is substantially equivalent to these predicates based on the provided comparison. No new clinical trials or performance studies with specific acceptance criteria are detailed in this summary. The FDA's letter (DEC 22 1997) confirms their finding of substantial equivalence, allowing the device to be marketed.

Summary

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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: (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:

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)

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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 numberAttachments 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 fromUnimar. Inc.	K895403web 510k	E	E	S	S	E	S	N/A	E	E	S	N/A	E	E	E	E	N/A
2- SelectMucus fromSelect Medical Systems, Inc.	K954102web 510k	E	E	S	S	E	S	N/A	E	E	S	N/A	E	E	E	E	N/A
3- Cervical Mucous Aspiration Catheterfrom Cook Urological. Inc.	K960263web 510k& 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 (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

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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)

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).