(64 days)
Not Found
No
The device description and performance studies focus on the physical properties of the pad (friction reduction) and its use in tactile examination, with no mention of AI or ML technologies.
No.
The device is indicated as an "aid for performing breast self-examination", which is a screening or diagnostic activity. It does not treat a condition.
No
The "Intended Use / Indications for Use" states that the device is "an aid for performing breast self-examination," which is a screening or self-monitoring activity, not a diagnostic one. While it aids in the detection of abnormalities (lumps), it does not provide a medical diagnosis itself.
No
The device description clearly states it is a physical bladder containing fluid, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an aid for performing breast self-examination". This is a physical aid for a manual examination, not a test performed on biological samples in vitro (outside the body).
- Device Description: The description details a physical pad with lubricating fluid designed to reduce friction during a tactile examination. It does not involve analyzing biological samples like blood, urine, or tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory testing. The performance studies focus on the tactile detection of lumps and the physical properties of the device (friction reduction).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device facilitates a physical examination, which is a different category of medical device.
N/A
Intended Use / Indications for Use
"The Sensor Pad® is indicated as an aid for performing breast selfexamination."
Product codes (comma separated list FDA assigned to the subject device)
90 IXH, 90 IYO
Device Description
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Street |
| Decatur, Illinois 62521 | |
| Contact Person: | Grant Wright, President |
| Telephone: | (217) 423-6911 |
| Fax: | (217)423-7282 |
-
- Name of Device:
Trade/Proprietary Name:
- Name of Device:
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
1
11973450 ド 201 レ
Premarket Notification Inventive Products, Inc. - Sensor Pad® September 9, 1997
4. Device Description
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.
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.
2
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
3
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)
4
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
6
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)
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