(88 days)
Not Found
No
The device description focuses on the mechanical and electrical components of the lithotripter and fluoroscopy system. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is intended to fragment urinary stones, which is a therapeutic intervention.
No
The device is described as an extracorporeal shock wave lithotripter intended to fragment urinary stones. While it uses fluoroscopy for targeting the stones, its primary function is therapeutic (fragmentation of stones) rather than diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly outlines hardware components such as spark gap dual heads, ellipsoid reflectors, water cushions, a motorized table, U-arm movements, and a fluoroscopy system. This indicates it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device, the Twinheads® TH-101 Extracorporeal Shock Wave Lithotripter, is used to treat patients directly by fragmenting kidney and ureteral stones within the body using shock waves.
- The intended use clearly describes a therapeutic procedure. The purpose is to fragment stones inside the patient, not to analyze samples outside the body.
- The device description details a physical treatment mechanism. It describes generating and focusing shock waves to break up stones, which is a therapeutic action, not a diagnostic test performed on a specimen.
Therefore, based on the provided information, the Twinheads® TH-101 Extracorporeal Shock Wave Lithotripter is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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).
Product codes (comma separated list FDA assigned to the subject device)
78 LNS
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter)
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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
§ 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.”)
0
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, LLC
8382 C Terminal Road
Lorton, 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
1
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 | Min
7 kV | Typical
11 kV | MAX
14 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 & Target
Location (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.
2
8. Summary of nonclinical studies
The Twinheads® TH-101 conforms to the following consensus standards:
| IEC 60601-2-36 | Particular Requirements for Safety Equipment for
Extracorporeally 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 Safety
Collateral Standard: Electromagnetic Compatibility
Requirements and Tests |
| IEC 60601-1-3 | Medical Electrical Equipment Part 1-3,
General Requirements for Safety
Collateral Standard: General Requirements for
Radiation Protection in Diagnostic X-Ray
Equipment |
| 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 Associated
Equipment 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.
3
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.
4
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
5
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