(450 days)
The Sontra Medical Corporation SonoPrep™ Impedance Diagnostics (IDx) System is intended to be used for preparation of intact skin to lower skin impedance. The supplied electrodes are intended to be used for ECG monitoring.
The Sontra Medical Corporation SonoPrep™ Impedance Diagnostics (IDx) System consists of a microprocessor controlled ultrasonic skin prep generator, a reusable handpiece, a reusable handheld contact electrode, coupling media and ECG electrodes used for ultrasonically treating intact skin in order to lower the skin impedance for the application of ECG electrodes for monitoring heart rates.
The provided document is a 510(k) summary for the Sontra Medical Corporation's SonoPrep™ Impedance Diagnostics (IDx) system. This document is a premarket notification to establish substantial equivalence to a legally marketed predicate device, rather than a detailed study report with specific acceptance criteria and performance metrics typically found in clinical trials for new drug or device approvals.
Therefore, the information about acceptance criteria and detailed study results is very limited in this document. Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state numerical acceptance criteria in a table format. However, it implies that the device's performance was evaluated against the predicate device (Quinton, Inc. QuikPrep Electrode System, K782079) regarding ECG waveform morphology, long-term impedance, and safety (skin irritation).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Comparable ECG waveform morphology to predicate device | Clinical studies showed no difference in ECG waveform morphology as compared to the predicate device. |
| Comparable long-term impedance to predicate device | Clinical studies showed no difference in long-term impedance as compared to the predicate device. |
| Acceptable safety profile (e.g., minimal adverse events) | Some patients developed redness at the treated sites which resolved within 24 hours and required no further follow-up treatment. |
| Ability to lower skin impedance for ECG monitoring | Demonstrates that the SonoPrep IDx reduced skin monitoring. (This statement appears fragmented and likely refers to reducing skin impedance.) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document only mentions "Clinical studies" and "Some patients."
- Data Provenance: Not specified (e.g., country of origin). The document indicates "Clinical studies," suggesting prospective data collection. It does not mention retrospective data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not available in the provided text. The evaluation method described focuses on comparison to a predicate device and direct observation of physiological effects (ECG morphology, impedance, skin reaction), rather than expert-derived ground truth for diagnostic accuracy.
4. Adjudication method for the test set:
This information is not available in the provided text.
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:
This is not applicable to this device. The SonoPrep IDx System is for preparing skin for ECG monitoring, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable to this device. The SonoPrep IDx System is a physical device that preconditions the skin, not an algorithm.
7. The type of ground truth used:
The ground truth or reference standard implicitly used for this device's performance evaluation was a comparison to a legally marketed predicate device (Quinton, Inc. QuikPrep Electrode System). The "ground truth" for showing effectiveness involved measuring physiological parameters (ECG waveform morphology, long-term impedance) and observing clinical outcomes (skin irritation) in patients treated with both the new device and the predicate.
8. The sample size for the training set:
There is no mention of a training set. This type of device (skin preparation for ECG) would typically involve clinical testing rather than machine learning training.
9. How the ground truth for the training set was established:
Since there is no mention of a training set, this information is not applicable.
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JAN 2 8 2004
510(k) Summary of Safety and Effectiveness
| Submitter: | Sontra Medical Corporation10 Forge ParkwayFranklin, MA 02038 |
|---|---|
| Contact Person: | Albert FarinhaDirector of Clinical and Regulatory AffairsTelephone: 508-553-8850 x224Fax: 508-553-8720sfarinha@sontra.com |
| Date: | January 11, 2004 |
| Trade Name: | SonoPrep™ Impedance Diagnostics (IDx) |
| Common Name: | Electrocardiograph (ECG) Electrode |
| Classification Namesand References: | Cardiovascular Monitoring Devices, 21 CFR870.2360, Electrocardiograph Electrode. |
| Predicate Device: | Quinton, Inc. QuikPrep Electrode System,K782079 |
| Device Description: | The Sontra Medical CorporationSonoPrep™ Impedance Diagnostics (IDx)System consists of a microprocessorcontrolled ultrasonic skin prep generator, areusable handpiece, a reusable handheldcontact electrode, coupling media and ECGelectrodes used for ultrasonically treatingintact skin in order to lower the skinimpedance for the application of ECGelectrodes for monitoring heart rates. |
| Intended Use: | Use of these products is indicated for thepreparation of intact skin to lower skinimpedance. The supplied electrodes areintended to be used for ECG monitoring. |
| Technological Characteristics: | The SonoPrep IDx system uses low levelultrasonic energy to create cavitation in acoupling solution which results in thecavitation in the handpiece that causes theoutermost layer of skin, the stratumcorneum, to become increasingly |
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conductive. The increased conductance or lower impedance improves the signal to noise ratio which is important in ECG monitoring.
Bench testing, clinical testing and biocompatibility data demonstrate that the device is comparable to previous cleared devices. Clinical studies showed no difference in ECG waveform morphology or long term impedance as compared to the predicate device. Some patients developed redness at the treated sites which resolved within 24 hours and required no further follow-up treatment.
Performance Data:
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
'JAN 2 8 2004
Sontra Medical, Inc. c/o Mr. Albert Farinha Director of Regulatory and Clinical Affairs 58 Charles Street Cambridge, MA 02141
Re: K023713
Trade Name: SonoPrep™ Impedance Diagnostics (IDx) System Regulation Number: 21 CFR 870.2370 Regulation Name: Electrocardiograph Surface Electrode Tester Regulatory Class: Class II (two) Product Code: KRC Dated: November 4, 2003 Received: November 7, 2003
Dear Mr. Farinha:
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 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.
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Page 2 - Mr. Albert Farinha
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 (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/dsma/dsmamain.html
Sincerely yours,
Donna R. Vachner
J. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 3 – Statement of Indications for Use
510(k) Number: Ko23913
Device Name: Sontra Medical Corporation SonoPrep™ Impedance Diagnostics (IDx) System
Intended Use / Indications for Use:
The Sontra Medical Corporation SonoPrep™ Impedance Diagnostics (IDx) System is intended to be used for preparation of intact skin to lower skin impedance. The supplied electrodes are intended to be used for ECG Impedance. The Supplied Stock onstrated that the SonoPrep IDx reduced skin monitoring. Olimour rooms when used in conjunction with the supplied ECG impediation for 21 how patients developing skin irritation. However, any skin irritation resolved within a 24 hour period.
Environment of Use / Patient Population:
- Handpiece: For multiple patient use in physician's office or hospital/institutional environment.
- Electrodes: For single patient use on adult patients (>30kg).
(PLEASE DO NOT WRITE BELOW THIS LINE/CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Donna R. Vichnes
Division of Cardiovascular & Respiratory Devices
510(k) Number K023713
Prescription Use
(per 21 CFR 801.109)
OR
Over the Counter Use _ Optional Format 1-2-96
§ 870.2370 Electrocardiograph surface electrode tester.
(a)
Identification. An electrocardiograph surface electrode tester is a device used to test the function and application of electrocardiograph electrodes.(b)
Classification. Class II (performance standards).