(169 days)
Not Found
No
The summary describes a device that uses ultrasonic energy to disrupt the skin for topical anesthetic application. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text.
Yes
The device is indicated for temporary disruption of the outer layer of skin to enhance the action of a topical anesthetic for pain reduction during needle insertion or IV procedures, which is a therapeutic purpose.
No
This device is intended to temporarily disrupt the skin for enhanced delivery of a topical anesthetic. It is not used to diagnose any medical condition or disease.
No
The device description explicitly states it is a "portable battery operated reusable device" that uses "ultrasonic energy" to disrupt the skin, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary disruption of the outer layer of skin prior to the application of a topical anesthetic for local dermal anesthesia. This is a procedure performed on the body (in vivo), not on samples taken from the body (in vitro).
- Device Description: The device description details a system that disrupts the skin using ultrasonic energy. This is a physical interaction with the body, not a test performed on a biological sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the detection of specific substances or markers within those samples, which are hallmarks of IVD devices.
Therefore, the SonoPrep® Ultrasonic Skin Permeation System is a device used for a medical procedure performed directly on a patient, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The SonoPrep® Ultrasonic Skin Permeation System and Procedure Tray is indicated for the 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.
Product codes (comma separated list FDA assigned to the subject device)
NRJ
Device Description
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%.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Randomized, controlled study.
Sample Size: 320 subjects.
Key Results: 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.
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
§ 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.
0
AUG 1 7 2004
:
K040525 (ps 1 of 2 )
SUMMARY OF SAFETY AND EFFECTIVENESS
| 510(k) Summary of Safety
and Effectiveness | Information supporting claims of substantial equivalence, as defined
under the Federal Food, Drug and Cosmetic Act, respecting safety and
effectiveness is summarized below. For the convenience of the
Reviewer, this summary is formatted in accordance with the Agency's
final rule"...510(k) Summaries and 510(K) Statements..." (21 CFR
807) and can be used to provide a substantial equivalence summary to
anyone requesting it from the Agency. |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | MODIFIED DEVICE NAME: SonoPrep® Ultrasonic Skin Permeation
System and Procedure Tray
EXISTING 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 selected
as the predicate devices for this submission. |
| Device Description | 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%. |
| Intended Use | The SonoPrep® Ultrasonic Skin Permeation System and Procedure
Tray is indicated for the 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. |
| Indications Statement | The SonoPrep® Ultrasonic Skin Permeation System is indicated for the
rapid production of local dermal anesthesia using topical OTC
lidocaine 4%. |
| Technological
Characteristics | The SonoPrep® Ultrasonic Skin Permeation System is technologically
identical to the predicate device. Changes include modified materials,
a disposable procedure tray and expanded indications for use. |
1
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
2
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.
3
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
4
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
ign-Off) (Division Division of General, Restorative, and Neurologica! Devices
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KOYOSZS 510(k) Number_