(206 days)
Not Found
No
The description mentions "micro-processor control of the operating parameters" but does not include any language suggesting AI or ML capabilities, such as image processing, learning algorithms, or data-driven decision making beyond basic parameter control.
Yes
The device is indicated for the treatment of chronic, full-thickness diabetic foot ulcers, which is a therapeutic application.
No
The device description and intended use indicate that the DUOLITH SD1 is used to treat chronic, full-thickness diabetic foot ulcers by providing acoustic pressure shockwaves. There is no mention of it being used to diagnose conditions or diseases.
No
The device description clearly outlines physical components like a hand-held applicator, coil system, metallic membrane, and parabolic reflector, which are hardware elements. While it mentions microprocessor control, this is part of the hardware system, not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The DUOLITH SD1 T-Top & Tower System with C-ACTOR Sepia Handpiece is a therapeutic device that delivers acoustic pressure shockwaves directly to the patient's body (specifically, diabetic foot ulcers). It is used for treatment, not for analyzing samples taken from the body.
- Intended Use: The intended use clearly states it is for the "treatment of chronic, full-thickness diabetic foot ulcers." This is a therapeutic application, not a diagnostic one.
The device description and performance studies further support that this is a therapeutic device used to promote wound healing, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The DUOLITH SD1 T-Top & Tower System with C-ACTOR Sepia Handpiece is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The DUOLITH SD1 with C-ACTOR is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.
Product codes (comma separated list FDA assigned to the subject device)
PZL
Device Description
The DUOLITH SD1 with the C-ACTOR Sepia Handpiece uses an electromagnetically generated shock wave produced within the hand-held applicator. The shock wave is generated by discharging a high voltage capacitor located in the Control Unit into a cylindrically shaped coil system in the C-ACTOR Handpiece which is surrounded by a cylindrical metallic membrane. The transient magnetic field produced by the coil induces eddy currents in the metal membrane, causing it to repel from the coil, producing a pressure wave. The membrane is immersed in water and the pressure wave produced by the membrane propagates through the water to a concentric parabolic reflector, where it is reflected to a focal point outside of the Handpiece in front of the reflector. The DUOLITH SD1 with C-ACTOR incorporates micro-processor control of the operating parameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult (22 years and older)
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)
Nonclinical performance: Nonclinical verification and validation testing was performed and demonstrated that the DUOLITH SD1 with C-ACTOR meets the design specifications and is safe and effective for its intended use. All tests required by the verification and validation plan were completed and passed. The testing demonstrates that the DUOLITH SD1 with C-ACTOR is substantially equivalent to the predicate devices. The DUOLITH SD1 software was validated and demonstrated to be of a Moderate level of concern; while hazard analysis / risk management was performed and demonstrated that all risks are mitigated to an acceptable level. There are no direct body contacting components since the treatment handpiece is separated from direct patient contact by a sterile barrier during treatment. However the treatment head component was nevertheless tested for biocompatibility (contact duration
§ 878.4685 Extracorporeal shock wave device for treatment of chronic wounds.
(a)
Identification. An extracorporeal shock wave device for treatment of chronic wounds is a prescription device that focuses acoustic shock waves onto the dermal tissue. The shock waves are generated inside the device and transferred to the body using an acoustic interface.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must be conducted to demonstrate that the system produces anticipated and reproducible acoustic pressure shock waves.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance data must demonstrate that the reusable components of the device can be reprocessed for subsequent use.
(4) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety of the device.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Performance data must support the use life of the system by demonstrating continued system functionality over the labeled use life.
(7) Physician labeling must include:
(i) Information on how the device operates and the typical course of treatment;
(ii) A detailed summary of the device's technical parameters;
(iii) Validated methods and instructions for reprocessing of any reusable components; and
(iv) Instructions for preventing hearing loss by use of hearing protection.
(8) Patient labeling must include:
(i) Relevant contraindications, warnings, precautions, adverse effects, and complications;
(ii) Information on how the device operates and the typical course of treatment;
(iii) The probable risks and benefits associated with the use of the device;
(iv) Post-procedure care instructions; and
(v) Alternative treatments.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
February 21, 2021
Storz Medical AG % Michael Dayton Principal Consultant Biomed Research. Inc. 3959 Van Dyke Road, Suite 245 Lutz, Florida 33558
Re: K202112
Trade/Device Name: Storz Medical DUOLITH SD1 T-Top & Tower System with C-ACTOR Sepia Handpiece Regulation Number: 21 CFR 878.4685 Regulation Name: Extracorporeal Shock Wave Device for Treatment of Chronic Wounds Regulatory Class: Class II Product Code: PZL Dated: January 20, 2021 Received: January 22, 2021
Dear Michael Dayton:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K202112
Device Name
DUOLITH SD1 T-Top & Tower System with C-ACTOR Sepia Handpiece
Indications for Use (Describe)
The DUOLITH SD1 T-Top & Tower System with C-ACTOR Sepia Handpiece is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The DUOLITH SD1 with C-ACTOR is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
1. SPONSOR
Storz Medical AG Lohstampfestr. 8 CH-8274 Tägerwilen Switzerland
| Contact Person: | Pavel Novak, Ph.D. |
|---|---|
| Telephone: | 41 (0) 71 677 45 13 |
| FAX: | 41 (0) 71 677 45 05 |
Date Prepared: February 19, 2021
2. DEVICE NAME
| Proprietary Name: | DUOLITH SD1 T-Top & Tower System with C-ACTOR Sepia Handpiece |
|---|---|
| Regulation Name: | Extracorporeal Shock Wave Device for Treatment of Chronic Wounds |
| Classification Panel: | General and Plastic Surgery Devices |
| Regulatory Number: | 21 CFR 878.4685 |
| Product Code: | PZL |
| Device Class: | II |
3. PREDICATE DEVICES
Equivalence is claimed to the predicate devices: DERMAPACE device (DEN160037; primary) and the ORTHOGOLD device (K191961).
4. DEVICE DESCRIPTION
The DUOLITH SD1 with the C-ACTOR Sepia Handpiece uses an electromagnetically generated shock wave produced within the hand-held applicator. The shock wave is generated by discharging a high voltage capacitor located in the Control Unit into a cylindrically shaped coil system in the C-ACTOR Handpiece which is surrounded by a cylindrical metallic membrane. The transient magnetic field produced by the coil induces eddy currents in the metal membrane, causing it to repel from the coil, producing a pressure wave. The membrane is immersed in water and the pressure wave produced by the membrane propagates through the water to a concentric parabolic reflector, where it is reflected to a focal point outside of the Handpiece in front of the reflector. The DUOLITH SD1 with C-ACTOR incorporates micro-processor control of the operating parameters.
4
ડાં INTENDED USE
The DUOLITH SD1 C-ACTOR Handpiece is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm, which extend through the exidermis, dermis, tendon, or capsule, but without bone exposure. The DUOLITH SD1 with C-ACTOR is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The technological characteristics of the DUOLITH SD1 and the predicate devices are the same with the exception of acoustic wave generation. The predicate devices utilize a high voltage spark plug to initiate a shock wave, while the Duolith utilizes a high voltage electrical coil. Both methods generate a short, high amplitude pulse (shock wave) of about 5 micro-seconds duration and results in similar waveforms and output energies.
7. PERFORMANCE TESTING
Nonclinical Performance
Nonclinical verification and validation testing was performed and demonstrated that the DUOLITH SD1 with C-ACTOR meets the design specifications and is safe and effective for its intended use. All tests required by the verification and validation plan were completed and passed. The testing demonstrates that the DUOLITH SD1 with C-ACTOR is substantially equivalent to the predicate devices.
The DUOLITH SD1 software was validated and demonstrated to be of a Moderate level of concern; while hazard analysis / risk management was performed and demonstrated that all risks are mitigated to an acceptable level. There are no direct body contacting components since the treatment handpiece is separated from direct patient contact by a sterile barrier during treatment. However the treatment head component was nevertheless tested for biocompatibility (contact duration