(30 days)
Not Found
No
The device description and the lack of mentions of AI, ML, image processing, training/test sets, or performance metrics strongly suggest this is a physical aid for self-examination, not a software-based device utilizing AI/ML.
No
The device is an aid for performing breast self-examinations, which is a screening or detection activity, not a treatment or therapeutic intervention.
No.
The device is described as an "aid for performing breast-self examinations" to help detect abnormalities, but it does not diagnose medical conditions. It assists in the physical examination, which can then lead to a diagnostic process if abnormalities are found.
No
The device description explicitly states it is made of physical materials (polyurethane and lubricant) and is a physical aid for breast self-examination, not a software application.
Based on the provided information, the Liv™ Breast Self Examination Aid is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Liv™ Device Function: The Liv™ device is a physical aid used on the body during a breast self-examination. It facilitates the tactile examination of breast tissue. It does not analyze any biological specimens.
- Intended Use: The intended use is to aid in a physical examination, not to perform a diagnostic test on a sample.
Therefore, the Liv™ Breast Self Examination Aid falls under the category of a medical device, but specifically not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Liv™ Breast Self Examination Aid is indicated as an aid for performing breast-self examinations.
Product codes
IZH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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
-
- 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
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name. if known:
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 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.
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.
-
- 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*]
- 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.
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
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