The Liv™ Breast Self Examination Aid is indicated as an aid for performing breast-self examinations. The device is made of soft, latex-free polyurethane and filled with a non-toxic lubricant. While allowing the breast tissue to remain in place during an exam, your fingers can still move effortlessly across the breast while detecting abnormalities.

AI/ML Overview

The provided text is a 510(k) summary for the Liv™ Breast Self Examination Aid. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed studies with specific acceptance criteria and performance metrics for the new device.

Based on the provided text, here's what can be extracted and what information is not available:

1. A table of acceptance criteria and the reported device performance

No direct acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are provided in this 510(k) summary. The submission primarily relies on demonstrating substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a clinical study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. The document does not describe a clinical study with a ground truth established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. The document does not describe a clinical study with a test set requiring adjudication.

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 breast self-examination aid and not an AI-powered diagnostic device. No MRMC study was conducted or described.

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

Not applicable. This is not an algorithm; it's a physical device used by individuals for self-examination.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The document does not describe a study involving ground truth.

8. The sample size for the training set

Not applicable. The device is not an AI algorithm requiring a training set.

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

Not applicable. The device is not an AI algorithm, so there is no training set or ground truth for it.

Summary of available information regarding acceptance criteria and study:

The Liv™ Breast Self Examination Aid is cleared based on demonstrating substantial equivalence to a previously cleared predicate device, the My Breast Friend device (K023390).

Acceptance Criteria (Implied by Substantial Equivalence):

Identical in materials and functionality: The device must be made of materials and operate in a manner that is sufficiently similar to the predicate device. The summary states: "In summary, the Liv™ Breast Self Examination Aid meets or exceeds all safety requirements for a device in its regulatory class and is found to be identical in materials and functionality when compared to the stated predicate device."
Safety and Effectiveness: The device must meet or exceed all safety requirements for its regulatory class and be deemed safe and effective for its intended use, as determined through comparison with the predicate.
Compliance with general controls: The device must comply with general controls provisions of the Act, including annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
Intended Use Match: The intended use of the new device must be the same as or very similar to the predicate device. The intended use for both the Liv™ device and implicitly the predicate is "as an aid for performing breast-self examinations."

Study/Evidence that proves the device meets the acceptance criteria:

The primary "study" in this context is the substantive equivalence comparison to the predicate device, My Breast Friend (K023390).

Methodology: The submission highlights that the Liv™ Breast Self Examination Aid is "identical in materials and functionality when compared to the stated predicate device." This suggests a comparative analysis of the device's physical properties (soft, latex-free polyurethane, non-toxic lubricant) and its mechanism of action (allowing fingers to move effortlessly across breast tissue while detecting abnormalities) against the predicate.
Predicate Device: My Breast Friend device from MBF Sales, LLC (K023390).
Conclusion: The FDA reviewed the 510(k) submission and determined "the device is substantially equivalent... to legally marketed predicate devices." This determination itself serves as the "proof" that the device met the regulatory acceptance criteria for market clearance under the 510(k) pathway.

This type of 510(k) submission does not typically involve new clinical performance studies with acceptance criteria for sensitivity, specificity, etc., unless there are significant differences between the new device and the predicate that could affect safety or effectiveness. For a physical aid such as this, the focus is on material safety and functional equivalence.

Summary

{0}------------------------------------------------

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E. Section 807.92.

1) Submitter's name, address, telephone number, contact person:

Ulli Haslacher MAR 0 8 2007 President Liv International USA, Inc. 2335 West Foothill Blvd., Suite 14 and 15, Upland, CA 91784

Phone: (909) 931-1719 Fax: (909) 931-1947

Email: ulli@livinternational.com

Date prepared: 5 January 2007

1. Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name. if known:
  Common/Usual Name

Liv™ Breast Self Examination Aid

Proprietary Name

Liv™ Breast Self Examination Aid

Classification Names

Mammographic X-ray system (892.1710; IZH, requlatory class II)

3) Identification of the predicate or legally marketed device:

Liv International USA, Inc. believes that the Liv™ Breast Self Examination Aid is substantially equivalent to the previously cleared My Breast Friend device from MBF Sales, LLC (Rockville, MD). The predicate 510(k) number is K023390.

Liv International USA. Inc.

{1}------------------------------------------------

4) Device Description:

The Liv ™ Breast Self Examination Aid is designed to comply with the standards listed below:

Premarket Notification 510(k): Regulatory Requirements for Medical . Devices, HHS Publication FDA 95-4158 (1995).
ISO14971 Medical devices- application of risk management to medical . devices (2000).

The Liv™ Breast Self Examination Aid will be cleared and/or approved by the following agencies:

U.S. Food and Drug Administration (FDA) .
European Medical Device Directive (MDD)- 93/42/EEC Notified Body .

5) Intended Use:

The Liv™ Breast Self Examination Aid is indicated as an aid for performing breast-self examinations.

6) Performance Standards:

Liv International USA. Inc. is not aware of any special controls or performance standards established for this device under sections 513 or 514 of the Food. Drug and Cosmetic Act.

7) Conclusion Statements:

In summary, the Liv™ Breast Self Examination Aid meets or exceeds all safety requirements for a device in its regulatory class and is found to be identical in materials and functionality when compared to the stated predicate device.

{2}------------------------------------------------

510(k) Summary/Statement Certification

Re: K070344 (not yo

CHECK ONLY ONE:

510(k) Summary. Attached is a summary of safety and effectiveness information upon which an equivalence determination could be based.

1. 510(k) Statement. I certify that, in my capacity as President of Liv ಂ International USA, Inc., I will make available all information in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, as defined in 21 CFR 20.61.
  [Signature*]

Ulli Haslacher
[Typed or Printed Name]

[Type of Printed Name]

January 15, 2007
[Date]

Must be signed by a responsible person of the firm required to submit the pre-market notification (e.g., not a consultant for the 510(k) submitter).

{3}------------------------------------------------

Image /page/3/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 stripes forming its wing and tail feathers. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAR 0 8 2007

Liv International USA, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, N.W. BUFFALO MN 55313

Re: K070344

Trade/Device Name: Liv " Breast Self Examination Aid Regulation Number: 21 CFR §892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: IZH Dated: February 5, 2007 Received: February 6, 2007

Dear Mr. Job:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/10 description: The image shows a circular logo with the text "FDA Centennial" and the years "1906-2006". The logo also features three stars at the bottom and text around the circle's perimeter. The central design includes the letters "FDA" in a bold, stylized font. The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration.

Protecting and Promoting Public Health

{4}------------------------------------------------

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.

This letter will allow you to begin marketing your device as described in your Section 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:

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 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html

Sincerely vours.

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

{5}------------------------------------------------

Indications for Use

K070344 510(k) Number (if known): 7BB-

Device Name: Liv™ Breast Self Examination Aid

Indications For Use:

The Liv™ Breast Self Examination Aid is indicated as an aid for performing breast-self examinations.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Broadon

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

Page 1 of 1

Regulation Number and Section

§ 892.1710 Mammographic x-ray system.

(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.