Laminaria is intended for use whenever it is desirable to dilate the cervical canal, such as Uterine curettage, Labor induction, IUD placement and removal, and Radium placement

Device Description

This single use device is a hygroscopic laminaria cervical dilator designed to dilate (stretch open) the cervical os by cervical insertion of a cylindrical and expansible material into the cervical canal, made from the root of a seaweed (laminaria digitata). Laminaria expands when it absorbs moisture.

The ability to increase in size slowly (usually 6 to 24 hours) is of advantage in physiologically dilating a closed body orifice such as the cervical canal. When used improperly, it may cause the patient major discomfort or uterine complications

Laminaria is available in 2, 3, 4, 5, 6, 7, 8 and 9 mm diameter sizes with a length varving between 50 and 65 mm. Each laminaria is drilled and attached to a 75-95 mm string to facilitate removal from the cervical canal (the last digit of the product code reflects its size)

Laminaria is intended for use whenever it is desirable to dilate the cervical canal, such as uterine or suction curettage, labor induction, IUD placement and removal, and Radium placement

AI/ML Overview

This 510(k) submission describes the Laminaria cervical dilator and claims substantial equivalence to a predicate device, the Staol Laminaria Tents from Norscan Trading Group. The submission focuses on demonstrating that the new device has identical characteristics to the predicate, rather than presenting a study to prove its performance against acceptance criteria in the typical sense of a novel device.

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of predefined acceptance criteria and a performance study against them, the submission uses a comparative approach against a predicate device. The "performance" is considered "identical" to the predicate.

Acceptance Criteria (Implied by Substantial Equivalence Claim)	Reported Device Performance (vs. Predicate)
Indications for use are met	Identical
Target population is appropriate	Identical
Design is appropriate	Identical
Materials are appropriate and safe	Identical
Performance characteristics are comparable	Identical
Sterility is achieved	Similar (Ethylene Oxide but different parameters)
Biocompatibility is maintained	Identical
Mechanical safety is ensured	Identical
Chemical safety is ensured	Identical
Anatomical sites are appropriate	Identical
Human factors are acceptable	Identical
Energy used and/or delivered is comparable	Identical
Compatibility with environment and other devices is ensured	Identical
Where used is appropriate	Identical
Standards are met	Identical
Electrical safety is ensured	Identical (not applicable)
Thermal safety is ensured	Identical (not applicable)
Radiation safety is ensured	Identical (not applicable)

2. Sample size used for the test set and the data provenance

The document does not describe a specific "test set" or clinical study with patient data. The argument for the device's safety and effectiveness relies on its technological characteristics being identical or similar to the predicate device, which is already legally marketed. Therefore, there's no data provenance in the context of a new clinical study. This is typical for a 510(k) submission where substantial equivalence is claimed based on similarities to a predicate rather than novel performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no new clinical "test set" was generated, there was no need for experts to establish ground truth for such a set.

4. Adjudication method for the test set

Not applicable. No new clinical "test set" was generated.

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 is a medical device (cervical dilator), not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance 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 device is a physical medical instrument, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context is the safety and effectiveness profile established for the predicate device. The underlying assumption is that because the Laminaria device is technologically equivalent to the predicate, it shares the same safety and effectiveness profile.

8. The sample size for the training set

Not applicable. There is no machine learning or AI component that would require a "training set."

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

Not applicable. There is no machine learning or AI component.

Summary

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K021012

JUN 2 5 2002

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

1-Submitter Name:	Quality Medical Solutions LLC
2-Address:	1308 Morningside Park DrAlpharetta, GA 30022 USA
3-Phone:	(678) 908-8180
4-Fax:	(425) 795-9341
5-Contact Person:	Jay Mansour
6-Date summary prepared:	March 25th, 2002
7-Device Trade or Proprietary Name:	Laminaria
8-Device Common or usual name:	Laminaria digitata
9-Device Classification Name:	Hygroscopic laminaria cervical dilator
10-Substantial Equivalency is claimed against the following device:

Staol Laminaria Tents from Norscan Trading Group ●

11-Description of the Device:

Laminaria is intended for use whenever it is desirable to dilate the cervical canal, such as uterine or suction curettage, labor induction, IUD placement and removal, and Radium placement

12-Intended use of the device:

Laminaria is intended for use whenever it is desirable to dilate the cervical canal, such as Uterine curettage, Labor induction, IUD placement and removal, and Radium placement

13-Safety and Effectiveness of the device:

This device (Laminaria) is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)

14-Summary comparing technological characteristics with other predicate device:

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

$\rho$ 6

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FDA file reference number	510k 951330
Attachments inside notification submission file	VERY IMPORTANT: REFER TO TABLE WITHIN MAIN SUBMISSION FOR DETAILS
TECHNOLOGICAL CHARACTERISTICS	Comparison result
Indications for use	Identical
Target population	Identical
Design	Identical
Materials	Identical
Performance	Identical
Sterility	Similar (Ethylene Oxide but different parameters)
Biocompatibility	Identical
Mechanical safety	Identical
Chemical safety	Identical
Anatomical sites	Identical
Human factors	Identical
Energy used and/or delivered	Identical
Compatibility with environment and other devices	Identical
Where used	Identical
Standards met	Identical
Electrical safety	Identical (not applicable)
Thermal safety	Identical (not applicable)
Radiation safety	Identical (not applicable)

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, arranged in a way that they appear to be interconnected.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 2002

Mr. Jay Mansour Director, Quality & Regulatory Quality Medical Solutions, LLC 1308 Morningside Park Road ALPHARETTA GA 30022

Re: K021012

Trade/Device Name: Laminaria 2mm, 3mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm Regulation Number: 21 CFR 884.4260 Regulation Name: Hygroscopic-Laminaria Cervical Dilator Regulatory Class: II Product Code: 85 HDY Dated: March 26, 2002 Received: March 29, 2002

Dear Mr. Mansour:

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.

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); 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.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely 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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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): //1

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

DESIRABLE LAMINARIA IS INDICATED FOR USE WHENEVER IT IS CERVICAL CANAL, SUCH AS UTERINE CURETTAGE , TO DILATE THE REHOVAL, AND LABOR INDULTION PLACEHENT TUD AND PLACE MENT KADIUM

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

Concurrenee of CDRH, Office of Device Evaluation (ODE)

David h. Bergman

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K01012

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

P 12

Regulation Number and Section

§ 884.4260 Hygroscopic Laminaria cervical dilator.

(a)
Identification. A hygroscopicLaminaria cervical dilator is a device designed to dilate (stretch open) the cervical os by cervical insertion of a conical and expansible material made from the root of a seaweed (Laminaria digitata orLaminaria japonica). The device is used to induce abortion.(b)
Classification. Class II (performance standards).