The Sensor Pad® is a thin polyether polyurethane bladder, 9.5 inches in diameter containing a small quantity of a lubricating fluid. The very thin nature of the polyether polyurethane allows the pad to conform to the shape of the tissues underlying it. The very low coefficient of friction property of the silicone fluid in combination with the very thin and flexible bladder, results in an easy sliding relationship between the upper and lower surfaces of the bladder. Therefore when properly used between the finger and the soft tissues of the patient, a reduction of friction is observed.

AI/ML Overview

The provided text describes the "Sensor Pad®," an aid for breast self-examination. The intent of the submission is to change its classification from "Prescription Use Only" to "OTC Use." The document primarily focuses on demonstrating substantial equivalence to a previously cleared device (K955249) and the safety and effectiveness for OTC use.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The device's acceptance criteria are not explicitly stated in numerical or qualitative thresholds. Instead, the reported performance is described conceptually as demonstrating the device's ability to reduce friction and its effectiveness in tactile detection of lumps. The key "acceptance" was the FDA's "substantial equivalence" determination for OTC use.

Acceptance Criterion (Implicit)	Reported Device Performance
Friction Reduction (ability to facilitate tactile examination)	Physical tests demonstrated the Sensor Pad's ability to reduce friction, as measured by the coefficient of friction.
Biocompatibility (safety of materials)	Biocompatibility data pertinent to the materials used in the manufacture of the Sensor Pad® were provided.
Tactile Detection of Lumps (effectiveness in BSE)	Clinical studies investigated the tactile detection of lumps using the Sensor Pad® as compared to using a lubricant and/or unaided detection.
Clinical Performance during BSE (overall utility)	Clinical studies investigated the clinical performance of the Sensor Pad® during breast self-examination.
Safety and Effectiveness for OTC Use	Additional testing was conducted to demonstrate that a change from "Prescription Use Only" to "OTC Use" does not alter the intended use or the safety or effectiveness of the device. The FDA's substantial equivalence determination inherently implies acceptance of the safety and effectiveness for its intended use, including the proposed OTC change, based on the provided evidence.

2. Sample Sizes and Data Provenance

The document mentions "six clinical studies" for performance testing. However, specific sample sizes for these studies are not provided. The data provenance (country of origin, retrospective/prospective) is also not specified.

3. Number of Experts and Qualifications

The document does not specify the number or qualifications of experts used to establish ground truth for any test set.

4. Adjudication Method

The document does not describe an adjudication method for any test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document mentions comparisons: "investigations of the tactile detection of lumps using the Sensor Pad® as compared to using a lubricant and/or unaided detection." While this suggests a comparative study, it does not explicitly state that it was an MRMC comparative effectiveness study involving human readers with and without AI assistance. The Sensor Pad® itself is not an AI device, but rather a physical aid. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not directly applicable in this context.

6. Standalone (Algorithm Only) Performance Study

The Sensor Pad® is a physical device, not an algorithm. Therefore, a standalone (algorithm only) performance study was not performed nor relevant for this product.

7. Type of Ground Truth Used

The document broadly refers to "tactile detection of lumps" and "clinical performance." The specific type of ground truth (e.g., expert consensus on palpation, pathology reports, or long-term outcomes data) used in the clinical studies is not explicitly detailed. It can be inferred that ground truth was established through clinical examination and potentially follow-up, but the method isn't specified.

8. Sample Size for the Training Set

The document does not mention a training set as this device is not an AI/machine learning model. The studies described are for validating the product's performance directly.

9. How Ground Truth for the Training Set was Established

As there is no training set for an AI/machine learning model, this information is not applicable.

Summary

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Premarket Notification Inventive Products Inc. - Sensor Pad® September 9, 1997

973450 8102

NOV 1 4 1997

510(k) SUMMARY Sensor Pad® September 9, 1997

This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510(k) premarket notification was in accordance with 21CFR 807.87 and the SMDA.

1. Submitter of 510(k)

Company Name:	Inventive Products, Inc.
Address:	1450 East North StreetDecatur, Illinois 62521
Contact Person:	Grant Wright, President
Telephone:	(217) 423-6911
Fax:	(217)423-7282

1. Name of Device:
  Trade/Proprietary Name:

Sensor Pad®

Common/Usual Name:

Aid for breast self-examination

Classification Name

21 CFR 892.1710 "Mammographic x-ray system (accessory)" Class I

ತೆ. Legally Market Predicate Devices

The Sensor Pad® cleared under 510(k) K955249

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11973450 ド 201 レ

Premarket Notification Inventive Products, Inc. - Sensor Pad® September 9, 1997

4. Device Description

Performance testing of the Sensor Pad's® use on tactile examination was extensively investigated. These studies were provided and described in detail. The reported data included descriptions of the protocols, findings, and conclusions. Physical tests demonstrated the Sensor Pad's® ability to reduce friction, as measured as the coefficient of friction. Biocompatibility data pertinent to the materials used in the manufacture of the Sensor Pad® were also provided. Six clinical studies were reported. These studies included investigations of the tactile detection of lumps using the Sensor Pad® as compared to using a lubricant and/or unaided detection, as well as the clinical performance of the Sensor Pad® during breast self-examination. Additional testing was also conducted to answer additional questions relating to OTC clearance. Results were provided and demonstrate that a change from "Prescription Use Only" to "OTC Use" does not in any way alter the intended use or the safety or effectiveness of this device.

5. Intended Use

The Sensor Pad® is indicated as an aid for performing breast selfexamination.

Substantial Equivalence હ.

The Sensor Pad® is physically identical and has the same indication for use as that previously cleared under K955249. This application is to change from "Prescription Use Only" to OTC. The Sensor Pad® previously cleared thus serves as the legally marketed predicate device. Valid scientific evidence, as discussed above, was provided to demonstrate the substantial equivalence determination.

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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 features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & H. MAN...S. USA" is arranged in a circular pattern around the bird symbol. The text is in all capital letters and is slightly blurred.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 1997

Mr. Grant A. Wright President Inventive Products, Inc. 1450 East North Street Decatur, Illinois 62521 Re: K973450 Sensor Pad® - OTC Dated: September 9, 1997 Received: September 11, 1997 Regulatory class: II 21 CFR §892.1710/Product code: 90 IXH

Dear Mr. Wright:

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, 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 are 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 vitto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note regulation entitled, the the state of the color of the more to the more of the reneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-fromuner (800) 638-204) or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

W.Liau Yu
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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Page 1 of 1

510(k) Number (if known):_K973450

Device Name: Sensor Pad

Indications For Use:

"The Sensor Pad is indicated as an aid for performing breast self-examination".

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive Abdominal

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K973450

Prescription Use (Per 21 CFR 801 109)

ੇ ਦ

Over-The-Counter Use_レ

.Counter Use ✓

(Optional Format 1-2-96)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 3 0 1998

Mr. Grant Wright President Inventive Products, Inc. 1450 East North Street Decatur, Illinois, 62521

Re: K973450

Sensor Pad® - OTC Dated: September 9, 1997 Received: September 11, 1997 Regulatory Class: II 21 CFR 892.1560 Product Code: 90 IYO

Dear Mr. Wright:

This letter corrects our substantially equivalent letter of November 11, 1997, regarding the CFR classification number from 892.1710 to 892.1560 and product code for 90 IXH to 90 IYO. We apologize for the error and any inconvenience it may have caused.

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 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). 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (I'DA) 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to continue 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.

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

Page -2 - Mr. Grant A. Wright

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) and add Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4699. Other general information on your responsibilities under the Office of obtained from the Division of Small Manufacturers Assistance at their toll frec number (800) 688-204) or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmanain.html".

Sincerely yours, 、『 ﺎﺭ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

Capt. Daniel G. Schultz, M.D. Acting 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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Page_1_of_1_ ::::「

510(k) Number (if known):_K973450

Device Name:___Sensor Pad

Indications For Use:

"The Sensor Pad is indicated as an aid for performing breast
self-examination" self-examination".

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number	K973450
---------------	---------

scription Use
---------------

Pres (Per 21 CFR 801. 109)

.. F

િત્ત

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

্র

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.