(206 days)
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.
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.
Here's an analysis of the provided text regarding the DUOLITH SD1 T-Top & Tower System with C-ACTOR Sepia Handpiece, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided FDA 510(k) summary does not explicitly list "acceptance criteria" in a quantitative, measurable format for performance, as might be found in a clinical trial protocol. Instead, it describes compliance with design specifications, safety standards, and then reviews clinical literature to demonstrate effectiveness.
Here's an interpretation of the performance claims based on the clinical literature review:
| Acceptance Criterion (Inferred from Clinical Literature) | Reported Device Performance |
|---|---|
| Effectiveness in achieving complete wound healing for chronic diabetic foot ulcers. | 54-70% complete wound healing at 13-20 weeks (reported from five independent studies). |
| Effectiveness in reducing wound area for chronic diabetic foot ulcers. | 35-80% reduction of wound area at 7-20 weeks (reported from five independent studies). |
| Safety for intended use. | Demonstrated through nonclinical verification and validation testing, hazard analysis/risk management (all risks mitigated), biocompatibility testing (ISO 10993-1:2009), and conformity to general safety (IEC 60601-1:2012; IEC 60601-6:2013), EMC (IEC 60601-1-2:2014), and RFID immunity (AMI 7351731) standards. |
| Compliance with design specifications. | All tests required by the verification and validation plan were completed and passed. |
| Substantial equivalence to predicate devices (DERMAPACE and ORTHOGOLD). | Demonstrated through technological characteristics comparison and the clinical effectiveness data being comparable to the expected outcomes for such devices. |
| Software validation. | Software validated to be of a Moderate level of concern. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: The document refers to a "review of published literature" that included "89 chronic soft tissue wounds having a range of etiologies including diabetes mellitus." This suggests that the clinical evidence is based on data from 89 patients (cases), at least, with a focus on chronic diabetic foot ulcers within that group. It's unclear if all 89 specifically had diabetic foot ulcers, but the indications for use focus on this specific condition.
- Data Provenance: The document states "The reports from five independent studies." This implies the data were collected from multiple sources, likely different medical institutions or research groups. The country of origin is not specified, nor is whether the studies were retrospective or prospective, though typical clinical studies used for such purposes are prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. As this relies on a literature review of previously published studies, the methodology for establishing ground truth within those original studies is not detailed here.
4. Adjudication Method for the Test Set
This information is not provided. As this relies on a literature review, the adjudication methods of the individual studies are not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done, or at least not described in this 510(k) summary. The document focuses on the device's standalone performance based on existing clinical literature, not on how human readers would improve with AI assistance. The DUOLITH SD1 is a therapeutic device, not a diagnostic AI tool, so an MRMC study comparing human reader performance with and without AI assistance would not be applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The entire clinical performance section describes the standalone effectiveness of the DUOLITH SD1 device in treating diabetic foot ulcers. The device itself is a therapeutic modality, and its "performance" is its ability to heal wounds or reduce wound area, independent of any human interpretive intervention like with an AI diagnostic algorithm. The results presented (wound healing rates, wound area reduction) represent the direct outcomes of using the device.
7. The Type of Ground Truth Used
The "ground truth" used in the clinical studies reviewed would be clinical outcomes data. Specifically:
- Complete wound healing (defined clinically, likely by visual inspection and measurement).
- Reduction of wound area (measured clinically).
8. The Sample Size for the Training Set
This information is not applicable/not provided because the DUOLITH SD1 is a medical device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves iterative design, engineering, and nonclinical testing to meet specifications, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As explained above, the device does not employ a machine learning model that would need a "training set" with established ground truth. Its development relies on engineering principles and nonclinical testing to ensure it meets performance specifications and safety standards.
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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.
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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
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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) |
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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.
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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 <24 hours) and found to conform to elements of ISO 10993-1:2009. The DUOLITH SD1 was tested and demonstrated to conform to the general safety requirements of IEC 60601-1:2012; IEC 60601-6:2013; and electromagnetic compatibility requirements of IEC 60601-1-2:2014; and the RFID electromagnetic immunity requirements of AMI 7351731.
No performance standards applicable to this device have been adopted under Section 514 of the Act. The DUOLITH SD1 System with C-ACTOR complies with the applicable requirements of the following international consensus standards:
- · ISO 14971: 2007: Medical devices: Application of risk management to medical devices.
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- · ISO 10993-1:2009 (4th Ed.): Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process.
- · ISO 61846:1998 Ultrasonics Pressure pulse lithotripters Characteristics of fields.
- · IEC 60601-1:2012, (3rd Ed.): Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
- · IEC 60601-2-36: 2014 (2nd Ed.): Medical electrical equipment Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy.
- · IEC 60601-1-2: 2014 (4th Ed.): Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- · IEC 60601-1-6: 2013 (3.1 Ed.): Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
- · AIM 7351731:2017 (Rev. 2.0): Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers.
- · IEC 62304:2015 (1.1 Ed.) Medical Device Software Software Life Cycle Process.
- · ISO 13485:2016: Medical devices Quality management systems Requirements for regulatory purposes.
Clinical Performance
A review of published literature with the subject device demonstrated successful clinical use with the Duolith SD1 technology in both men and women with 89 chronic soft tissue wounds having a range of etiologies including diabetes mellitus. The reports from five independent studies show significant results in complete wound healing (54-70% at 13-20 weeks) and reduction of wound area (35-80% at 7-20 weeks). The data from these studies establish the effectiveness of the Duolith SD1 to treat chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure.
The conclusions drawn from the nonclinical and clinical tests demonstrate that the Duolith SD1 is as safe, as effective, and performs as well as the legally marketed predicate devices.
8. SUBSTANTIAL EQUIVALENCE COMPARISON
| Product Comparison | Predicate DevicedermaPACE | Predicate DeviceOrthoGold 100 | Subject DeviceDUOLITH SD1 w/C-ACTOR |
|---|---|---|---|
| 510(k) Number | DEN160037 | K191961 | K202112 |
| Product Class | II | - Same - | - Same - |
| Classification Panel | General and Plastic Surgery Devices | - Same - | - Same - |
| Product Code andRegulation | 21 CFR 878.4685PZL - Extracorporeal Shock Wave Device forTreatment of Chronic Wounds | Same | - Same - |
| Indications for Use | To provide acoustic pressure shockwaves in thetreatment of chronic, full-thickness diabetic footulcers with wound areas measuring no largerthan 16 cm2, which extend through the | - Same - | - Same - |
| Modes of action | Focused pressure pulses | Unfocused pressurepulses | Focused pressurepulses |
| Mechanism of action | Extracorporeally induced pressure pulses | - Same - | - Same - |
| Operating mode | Continuous | - Same - | - Same - |
| Electrical Protection | Class I, B | - Same - | - Same - |
| User Interface | LCD with function keys | Touch Screen | Touch Screen |
| Firmware Controlled | Yes | Yes | Yes |
| Type of Energy | Pressure pulses | - Same - | - Same - |
| Energy Source | 100 - 240 V AC, 50-60 Hz | - Same - | - Same - |
| Type of AcousticWave Generation | Electrohydraulic, pressure wave under watercaused by discharge of high voltagecondensers | Electrohydraulic,pressure wave underwater caused bydischarge of highvoltage condensers | Electromagnetic,pressure wave underwater caused bydischarge of highvoltage condensers |
| Selection of parameters(Intensity, Frequency,Number of Pulses) | Yes | Yes | Yes |
| Size of treatmentapplicator heads | ø70 x 160 mm | ø70 x 230 mm | ø62 x 179 mm |
| Intensity SettingsRange (Min-max:Energy Flux Density) | 1 to 6(0.23 - 0.33mJ/mm2) | 1 to 16(0.01 - 0.19mJ/mm2) | 0.03 - 1.24mJ/mm2 |
| Focus depth | 1.5 - 10.5mm | 0 - 38mm"unfocused" | 0 - 30mm |
| Pulse repeat rate (1/s) | 1 - 4 Hz | 1 - 8 Hz | 1 - 8 Hz |
| Number of pulses(min and max) | 31.25 - 500 | 100 - 1000 | 100 - 500 |
| System Dimensions(W x H x D) | 473 x 219 x 427 mm | 400 x 218 x 459 mm | 454 x 187 x 460 mm |
| OperatingTemperature | N / A | 10° - 30°C | 10° - 30°C |
| Operating RelativeHumidity | N / A | 3 - 85% | 5 - 55% |
| Treatment Duration(Typical) | 5 — 10 min | 10 - 20 min | 10 - 20 min |
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§ 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.