(169 days)
The Sontra Medical Corporation SonoPrep® Ultrasonic Skin Permeation System and The Oollar Tray is indicated for the temporary disruption of the outer layer of skin prior to the application of OTC Topical 4% Lidocaine Cream, for local dermal anesthesia prior to a needle insertion or IV procedure.
The SonoPrep® Ultrasonic Skin Permeation System is a portable battery operated reusable device that disrupts the stratum corneum layer of the skin by means of cavitation of a fluid with ultrasonic energy. The result of the treatment allows the rapid onset of topical OTC lidocaine 4%.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets the acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria in a quantitative or tabular format. However, based on the study described, the implied performance criterion is the ability to produce a "rapid dermal anesthetic effect" using topical OTC lidocaine 4%, with no significant adverse events or skin irritation.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Produce a rapid dermal anesthetic effect using topical OTC lidocaine 4%. | Results demonstrated that the SonoPrep® Ultrasonic Skin Permeation System can produce a rapid dermal anesthetic effect using topical OTC lidocaine 4%. |
| No adverse events or significant skin irritation due to the treatment. | Analysis of clinical observations from 320 subjects taken approximately 24 hours after treatment revealed no adverse events or significant skin irritation due to the treatment. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: 320 subjects.
- Data Provenance: The study was a "randomized, controlled study." The country of origin is not explicitly stated, but the submission is to the FDA in the USA, suggesting the study was likely conducted there or in a location compliant with US regulatory standards. It was a prospective study, as subjects were treated and then their pain and adverse events were assessed.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications of Experts
The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of diagnostic accuracy. Instead, pain was assessed by the subjects themselves using an "accepted pain evaluation scale." The clinical observations for adverse events were likely made by clinical staff involved in the study, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. Pain scores were self-reported by subjects, and clinical observations for adverse events were analyzed. There's no indication of multiple reviewers or an adjudication process for these outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The study focused on the effectiveness of the device in facilitating anesthesia, not on human readers' performance with or without AI assistance.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done
This question is not applicable as the device is a physical system (SonoPrep® Ultrasonic Skin Permeation System) that is used in conjunction with a topical anesthetic, not a diagnostic algorithm. Therefore, there's no "algorithm only" performance to evaluate.
7. The Type of Ground Truth Used
The "ground truth" in this context is based on:
- Subjective Patient Outcomes: Pain scores reported by the subjects using an accepted pain evaluation scale.
- Clinical Observations: Assessment of adverse events and skin irritation by clinical personnel.
8. The Sample Size for the Training Set
The document does not describe a "training set" as this is a medical device for facilitating drug delivery, not a machine learning algorithm requiring training data. The "evaluations" mentioned (Laboratory and bench top) refer to engineering and design verification, not algorithm training.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated in point 8.
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AUG 1 7 2004
:
K040525 (ps 1 of 2 )
SUMMARY OF SAFETY AND EFFECTIVENESS
| 510(k) Summary of Safetyand Effectiveness | Information supporting claims of substantial equivalence, as definedunder the Federal Food, Drug and Cosmetic Act, respecting safety andeffectiveness is summarized below. For the convenience of theReviewer, this summary is formatted in accordance with the Agency'sfinal rule"...510(k) Summaries and 510(K) Statements..." (21 CFR807) and can be used to provide a substantial equivalence summary toanyone requesting it from the Agency. |
|---|---|
| MODIFIED DEVICE NAME: SonoPrep® Ultrasonic Skin PermeationSystem and Procedure TrayEXISTING DEVICE NAME: SonoPrep® Impedance Diagnostics(IDx) System | |
| 510(k) SUMMARY | |
| Predicate Devices | The Sontra Medical, SonoPrep® Impedance Diagnostics (IDx) System,K023713 and the Norwood Abbey, LAD-01, K021222, were selectedas the predicate devices for this submission. |
| Device Description | The SonoPrep® Ultrasonic Skin Permeation System is a portablebattery operated reusable device that disrupts the stratum corneum layerof the skin by means of cavitation of a fluid with ultrasonic energy.The result of the treatment allows the rapid onset of topical OTClidocaine 4%. |
| Intended Use | The SonoPrep® Ultrasonic Skin Permeation System and ProcedureTray is indicated for the disruption of the outer layer of skin prior to theapplication of OTC topical 4% lidocaine cream, for local dermalanesthesia prior to a needle insertion or IV procedure. |
| Indications Statement | The SonoPrep® Ultrasonic Skin Permeation System is indicated for therapid production of local dermal anesthesia using topical OTClidocaine 4%. |
| TechnologicalCharacteristics | The SonoPrep® Ultrasonic Skin Permeation System is technologicallyidentical to the predicate device. Changes include modified materials,a disposable procedure tray and expanded indications for use. |
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K040525 (pg 2 of 2)
510(k) Summary of Safety and Effectiveness Continued
Laboratory and bench top evaluations have determined that the Performance Data modifications comply with design requirements and meet or exceed the original design. An IRB approved randomized, controlled study was conducted involving 320 subjects. Full needle insertion of a 23G 5/8" needle was used as a standard pain stimulus. After treatment and needle insertion subjects were asked to rate the pain using an accepted pain evaluation scale; pain scores were tested and analyzed per the approved protocol. Results demonstrated that the SonoPrep® Ultrasonic Skin Permeation System can produce a rapid dermal anesthetic effect using topical OTC lidocaine 4%. Analysis of clinical observations from 320 subjects taken approximately 24 hours after treatment revealed no adverse events or significant skin irritation due to the treatment. Based on the 510(k) summaries and the 510(k) statements (21 CFR Conclusion 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food, Drug and Cosmetic Act. Albert Farinha Contact Director, Operations and Regulatory Affairs Sontra Medical Corporation 10 Forge Parkway Franklin, MA 02038 August 13, 2004 Date
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three horizontal lines representing its wings. The bird is enclosed in a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 7 2004
Mr. Albert Farinha Director of Operations and Regulatory Affairs Sontra Medical, Inc. 10 Forge Parkway Franklin. Massachusetts 02038
Re: K040525
Trade/Device Name: Sontra Medical Corporation SonoPrep® Ultrasonic Skin Permeation System and Procedure Tray Regulation Numbers: 21 CFR 878.4410, 21 CFR 878.4810 Regulation Names: Low energy ultrasound wound cleaner, Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: NRJ Dated: June 18, 2004 Received: June 21, 2004
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 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. However, you are responsible to determine that the medical devices you use as components in the tray have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 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 or any 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 the labeling regulation, please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification'(21 CFR 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.dsmamain.html.
Sincerely yours,
Atypt Qurdie
Celia M. Witten, Ph.D., M.D.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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14040525
Indications for Use
K040525 510(k) Number (if known):
Sontra Medical Corporation SonoPrep® Ultrasonic Skin Permeation Device Name: System and Procedure Tray
Indications For Use:
The Sontra Medical Corporation SonoPrep® Ultrasonic Skin Permeation System and The Oollar Tray is indicated for the temporary disruption of the outer layer of skin prior to the application of OTC Topical 4% Lidocaine Cream, for local dermal anesthesia prior to a needle insertion or IV procedure.
Prescription Use _ V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stipt. Iwdus
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KOYOSZS 510(k) Number_
§ 878.4410 Low energy ultrasound wound cleaner.
(a)
Identification. A low energy ultrasound wound cleaner is a device that uses ultrasound energy to vaporize a solution and generate a mist that is used for the cleaning and maintenance debridement of wounds. Low levels of ultrasound energy may be carried to the wound by the saline mist.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner.” See § 878.1(e) for the availability of this guidance document.