(88 days)
The Twinheads® TH-101 Extracorporeal Shock Wave Lithotripter is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
The Twinheads® TH-101 ESWL is a spark gap dual head shock wave lithotripter with an integrated fluoroscopy system for the fragmentation of kidney and ureteral calculi. The Twinheads® TH-101 delivers a pair of shock waves, which are separated from each other by a certain delay time, with perpendicular trajectories and overlapping focal zones. The pulse pairs or twin shocks are aligned with the calculi or stone utilizing the fluoroscopy system via two orientations. A rapid current pulse discharges through a small gap in each of the two heads. The pulse discharge creates a shock wave, which radiates outward. Two identical ellipsoid reflectors serve to reflect and focus the shock waves, which are transmitted into the patient by a water cushion through a membrane and contact gel. There are two shockwave sources and two cushions in the Twinheads® TH-101 ESWL. Also included are an accurate motorized table and U-arm movements, high resolution fluoroscopy, and efficient shock wave energy sources.
The provided document describes a 510(k) premarket notification for the Twinheads® TH-101 Extracorporeal Shock Wave Lithotripter. The acceptance criteria and the study proving the device meets them are outlined in section 7, "Clinical study."
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly refers to the special controls guidance for ESWL devices as the acceptance criteria. The specific performance metrics assessed in human clinical trials for a new ESWL device would typically include:
| Acceptance Criteria (Implied from FDA Guidance for ESWL) | Reported Device Performance |
|---|---|
| Safety: No unanticipated adverse effects. | "...the device was able to fragment stones successfully and not pose any unanticipated adverse effects." |
| Effectiveness/Functionality: Successful stone fragmentation for indicated uses (urinary stones in kidney and ureter). | "...the device was able to fragment stones successfully..." and "The results of the study confirmed the functionality of the device and the adequacy of the proposed labeling." |
| Adequacy of Labeling: Labels accurately reflect device capabilities and safe use. | "...the adequacy of the proposed labeling." |
2. Sample Size and Data Provenance for Test Set:
- Sample Size: 20 patients.
- Data Provenance: The study was conducted at "two sites." The document does not specify the country of origin, but given the 510(k) submission to the FDA, it is highly probable the data was collected in the United States.
- Retrospective or Prospective: Prospective, as it states "20 patients were treated" indicating a clinical trial was performed.
3. Number of Experts and Qualifications for Ground Truth:
The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., radiologist with 10 years of experience). In a clinical study for a lithotripsy device, the success of "stone fragmentation" would typically be assessed by the treating urologists or other medical specialists involved in post-procedure imaging and patient follow-up.
4. Adjudication Method for the Test Set:
The document does not specify an adjudication method (e.g., 2+1, 3+1) for assessing the outcomes of the clinical study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or indicated in this summary. The study described is a confirmatory clinical study to demonstrate the device's functionality, safety, and effectiveness, not a comparison of human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance:
No, a standalone (algorithm only) performance study was not conducted. This device is a physical medical device (Extracorporeal Shock Wave Lithotripter), not an AI algorithm. The study described assesses the device's ability to fragment stones in patients.
7. Type of Ground Truth Used:
The ground truth used was based on clinical outcomes (successful stone fragmentation) and safety assessments (absence of unanticipated adverse effects) in treated patients. While not explicitly detailed, these assessments would involve post-treatment imaging and clinical evaluation by medical professionals.
8. Sample Size for the Training Set:
The document does not mention a "training set" in the context of an AI/ML algorithm. This device is a physical lithotripsy machine; therefore, the concept of a training set for an algorithm is not applicable here. The "clinical study" described serves as the primary evidence for its intended use, rather than a separate training and test set distinction typically associated with AI.
9. How Ground Truth for Training Set Was Established:
As there is no training set for an AI algorithm, this question is not applicable. The device's fundamental design and technological characteristics (Section 6) are based on established physics and engineering principles, and its performance is validated through the clinical study.
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MAY - 2 2003
K030346
PG. 1 OF 3
510(k) Summary
This summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
Date of preparation: April 30, 2003
1. Sponsor information
| Name and address: | FMD, LLC8382 C Terminal RoadLorton, VA 22079 |
|---|---|
| Contact: | Yousry Faragalla, MD |
| Phone: | 703-339-8881 |
| Fax: | 703-339-2922 |
2. Device information
| Trade name: | Twinheads® TH-101 Extracorporeal Shock Wave Lithotripter |
|---|---|
| Common name: | Extracorporeal shock wave lithotripter |
| CFR Number: | 21 CFR 876.5990 – Extracorporeal shock wave lithotripter |
| Product code: | 78 LNS |
| Regulatory Class: | Class II (special controls) |
3. Substantial Equivalence
The Twinheads® TH-101 ESWL is substantially equivalent to the following legally marketed devices:
- EDAP Technomed, Inc. Sonolith Praktis (K003529) ■
- I PCK Electronic Industry and Trade Co., Inc. - Stonelith V5 (K011106)
4. Device description
The Twinheads® TH-101 ESWL is a spark gap dual head shock wave lithotripter with an integrated fluoroscopy system for the fragmentation of kidney and ureteral calculi. The Twinheads® TH-101 delivers a pair of shock waves, which are separated from each other by a certain delay time, with perpendicular trajectories and overlapping focal zones. The pulse pairs or twin shocks are aligned with the calculi or stone utilizing the fluoroscopy system via two orientations.
A rapid current pulse discharges through a small gap in each of the two heads. The pulse discharge creates a shock wave, which radiates outward. Two identical ellipsoid reflectors serve to reflect and focus the shock waves, which are transmitted
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Image /page/1/Picture/1 description: The image shows a document with the text "K030346" at the top, which appears to be a document or reference number. Below that, it says "PG 2 OF 3", indicating it is page 2 of a 3-page document. The text "Twinheads® TH-101 ESWL" is present, likely referring to a product name or model. Finally, the phrase "510(k) Premarket Notification" suggests the document is related to a medical device and its regulatory approval process.
into the patient by a water cushion through a membrane and contact gel. There are two shockwave sources and two cushions in the Twinheads® TH-101 ESWL.
Also included are an accurate motorized table and U-arm movements, high resolution fluoroscopy, and efficient shock wave energy sources.
5. Intended use
The Twinheads® TH-101 Extracorporeal Shock Wave Lithotripter is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
6. Technological characteristics
Shock wave characteristics are provided in the following table, which includes data for the minimum, typical, and maximum shock wave generator output settings.
| Parameter | Min7 kV | Typical11 kV | MAX14 kV |
|---|---|---|---|
| Peak-Positive Acoustic Pressure—(Mpa) | 41.5 | 86.5 | 110 |
| Peak-Negative Acoustic Pressure—(Mpa) | 12.5 | 26.2 | 32.6 |
| Rise Time (ns) | 42 | 47 | 52 |
| Compressional Pulse Duration (ns) | 420 | 470 | 492 |
| Maximum Focal Width (mm) | 10.4 | 12.8 | 15.6 |
| Orthogonal Focal Width (mm) | 9.6 | 12.2 | 15.4 |
| Focal Extent (mm) | 28.4 | 30.6 | 31.4 |
| Focal Volume (cm³) | 156 | 248 | 296 |
| Distance between Focus & TargetLocation (mm) on Z Axis | 1 | 5 | 6 |
| Derived Acoustic Pulse Energy (mJ) | 8.1 | 18.2 | 18.9 |
| Derived Acoustic Pulse Energy at R=4mm Radius (mJ) | 40.1 | 51.2 | 55.4 |
| Derived Acoustic Pulse Energy at R=7mm Radius (mJ) | 53.2 | 79.1 | 80.3 |
7. Clinical study
A confirmatory study as described in the FDA 510(k) guidance for ESWL was performed at two sites during which 20 patients were treated. The results of the study confirmed the functionality of the device and the adequacy of the proposed labeling, The safety and effectiveness of the device was also assessed through this study which concluded that the device was able to fragment stones successfully and not pose any unanticipated adverse effects. Therefore, the device has met the requirements for a confirmatory study as specified in the FDA Guidance Document.
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8. Summary of nonclinical studies
The Twinheads® TH-101 conforms to the following consensus standards:
| IEC 60601-2-36 | Particular Requirements for Safety Equipment forExtracorporeally Induced Lithotripsy |
|---|---|
| IEC 61846 | Ultrasonics- Pressure Pulse Lithotripters-Characteristics of Fields |
| IEC 60601-1-1 | Medical Electrical Equipment Part 1-1,General Requirements for Safety |
| IEC 60601-1-2 | Medical Electrical Equipment Part 1-2,General Requirements for SafetyCollateral Standard: Electromagnetic CompatibilityRequirements and Tests |
| IEC 60601-1-3 | Medical Electrical Equipment Part 1-3,General Requirements for SafetyCollateral Standard: General Requirements forRadiation Protection in Diagnostic X-RayEquipment |
| IEC 60601-2-7 | Medical Electrical Equipment Part 2-7,Particular Requirements for the Safety Of High-Voltage Generators of Diagnostic X-Ray Generators |
| IEC 60601-2-32 | Medical Electrical Equipment Part 2-32,Particular Requirements for the Safety of AssociatedEquipment of X-Ray Equipment |
9. Conclusion
The Twinheads® TH-101 Extracorporeal Shock Wave Lithotripter is substantially equivalent to legally marketed devices and conforms to the requirements of FDA's special controls document "Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi", August 9, 2000.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three lines representing the snakes and a central form representing the staff.
MAY - 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Yousry Faragalla, M.D. President FMD, LLC 8382C Terminal Road LORTON VA 22079
Re: K030346
Trade/Device Name: Twinheads® TH-101 Extracorporeal Shock Wave Lithotripter Regulation Number: 21 CFR 8876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: 78 LNS Dated: January 30, 2003 Received: February 3, 2003
Dear Dr. Faragalla:
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. Iisting 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 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.
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 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 one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K030346
Device Name: Twinheads® TH-101 Extracorporeal Shock Wave Lithotripter
Indication for Use:
The Twinheads® TH-101 Extracorporeal Shock Wave Lithotripter is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _X (Per 21 CFR 801.109) OR
Over-the-counter Use __
Carolyn Y Newland (for Nancy Brogdon)
Division Side Off
Intiste Ahdon
Indications for use
§ 876.5990 Extracorporeal shock wave lithotripter.
(a)
Identification. An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.(b)
Classification. Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)