(21 days)
The Twinheads® TH-103 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-103 ESWL is a spark gap dual head shock wave lithotripter for the fragmentation of kidney and ureteral calculi. The Twinheads® TH-103 delivers a pair of shock wayes, 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 legally marketed C-arm fluoroscopy system via two orientations. Also included is an accurate motorized table with carbon fiber top.
The provided document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device. The document describes a traditional medical device, a lithotripter, and its clearance process through a 510(k) submission.
Here's a breakdown of why the requested information is absent and what the document does say:
1. A table of acceptance criteria and the reported device performance
- Not applicable to this document. This document is for a physical medical device (Twinheads® TH-103 Extracorporeal Shock Wave Lithotripter), not an AI/ML device. Acceptance criteria for such a device would typically involve mechanical specifications, safety features, energy delivery parameters, and clinical efficacy (e.g., stone-free rates, re-treatment rates), which are not explicitly detailed as acceptance criteria in this summary. The "reported device performance" would typically be derived from clinical studies or non-clinical tests, neither of which are extensively detailed or used to establish "acceptance criteria" in this 510k summary.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable to this document. No test set in the context of AI/ML validation is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable to this document. No ground truth for an AI/ML algorithm is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable to this document. No adjudication method for an AI/ML test set is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable to this document. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable to this document. The device is a physical lithotripter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable to this document. No ground truth for an AI/ML algorithm is mentioned.
8. The sample size for the training set
- Not applicable to this document. No training set for an AI/ML algorithm is mentioned.
9. How the ground truth for the training set was established
- Not applicable to this document. No ground truth for an AI/ML algorithm is mentioned.
What the document does state regarding acceptance criteria and studies:
The document explicitly states:
- "No clinical studies were performed."
- The premise for clearance is substantial equivalence to a predicate device (Twinheads® TH-101 ESWL, K030346).
- The Twinheads® TH-103 ESWL is described as a "modification" of the predicate device, having the "same fundamental scientific technology and intended use."
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are interpreted as the FDA's "substantial equivalence" determination, based on the device having similar technological characteristics and intended use to a previously cleared device, without the need for new clinical data. The "proof" is the comparison to the predicate device and the claim that the modifications do not change the fundamental scientific technology.
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0C7 1 2 2004
510(k) Summary
This summary is being submitted in accordance with the requirements of 21 CFR 807.87.
Sponsor information 1.
Name and address: FMD, LLC
| P. O. Box 1500Lorton, VA 22199-1500 | |
|---|---|
| Contact: | Yousry Faragalla, MD |
| Phone: | 703-880-4642 |
| Fax: | 703-880-4643 |
| Email: | yfaragalla@fmdco.com |
2. Device information
| Trade name: | Twinheads® TH-103 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-103 ESWL is substantially equivalent to predicate legally marketed device Twinheads® TH-101 ESWL (K030346)
Device description 4.
The Twinheads® TH-103 ESWL is a spark gap dual head shock wave lithotripter for the fragmentation of kidney and ureteral calculi. The Twinheads® TH-103 delivers a pair of shock wayes, 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 legally marketed C-arm fluoroscopy system via two orientations. Also included is an accurate motorized table with carbon fiber top.
5. Intended use
The Twinheads® TH-103 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).
Technological characteristics 6.
-The Twinheads® TH-103 ESWL is a modification of Twinheads® TH-101 ESWL And has the same fundamental scientific technology and intended use.
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Twinheads® TH-103 ESWL Special 510(k) Premarket Notificat
7. Clinical study
No clinical studies were performed.
1. Conclusion
The Twinheads® TH-103 Extracorporeal Shock Wave Lithotripter is a modification and substantially THE TWIMEAGS® TTP TO Extraces porcer d device and conforms to the requirements of FDA for a equivalent to its predicate regard) a minor modification which does not change the fundamental scientific technology and intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces right and is positioned in the center of a circular emblem. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper perimeter of the circle.
Public Health Service
OCT 1 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Yousry Faragalla, M.D. President FMD, LLC P.O. Box 1500 LORTON VA 22199-1500
Re: K042561
R042501
Trade/Device Name: Twinheads® TH-103 Extracorporeal Shock Wave Lithotripter Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: 78 LNS Dated: September 17, 2004 Received: September 24, 2004
Dear Dr. Faragalla:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced in We have reviewed your Section 510(ts) premailed interestions for use stated in
above and have determined the device is substantially equivalent (for the stated in above and have determined the devices marketed in interstate commerce prior to the enclosure) to regarly marketed predicato do this Amendments, or to devices that have been May 28, 1976, the enactment date of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordatice with the proval application (PMA). You may, therefore, market the A do not require approval of a premance approvations of the Act. The general controls provisions of the Act. device, subject to the general controls provisions 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 (Premarket If your device is classince (see above) historial controls. Existing major regulations affecting your Approval), it may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA device can be round in the cours in concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA s Issualled of a subscannolies with other requirements of the Act or any
FDA has made a determination that your device complies with other requirem Federal statutes and regulations administered by other Federal agencies. You must comply with all the Federal statues and regulations administered of Casistration and listing (21 CFR Part 807); tabeling Act's requirements, including, but lot minted to registerials (21 CFR Part 801), good manufacturing practice the 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 Section 510(k) This letter will anow you to ocgin marketing your antial equivalence of your device to a legally premarket notification. The PDA Inding of Sacsamal equi Andress of Same of Same Starter to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device of our saveling organization number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Allso, please note the regulation entitled, "Association on your responsibilities under the Act from the 190 807.97). You may outlar other general manufacturer Assistance at its toll-free number (800).
Division of Small Manufacturers, International and Consumer (1 http://www.circus. Division of Small Manufacturers, International and Oottool/www.fda.gov/cdrb/dsmaldsmamain.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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FMD, LLC.
Indications for Use Statement
510(k) Number (if known): K042561
Device Name: Twinheads® TH-103 Extracorporeal Shock Wave Lithotripter
Indication for Use:
The Twinheads® TH-103 Extracorporeal Shock Wave Lithotripter is intended to The Twinneaus® TH-105 Extractive (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 _________________________________________________________________________________________________________________________________________________________
Nancy C. Boydon
(Division Sign Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 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.”)