(104 days)
The LithoGold is an extracorporeal shock wave lithotripsy device intended to fragment urinary stones in the kidney (renal pelvis and calyces) and ureter (upper, middle and lower).
The LithoGold is an extracorporeal shock wave therapy device designed for the non-invasive fragmentation of urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle and lower ureter). The LithoGold employs an electrohydraulic method of shock wave generation with both ECG gating and fixed frequency capabilities. The LithoGold unit will be combined with the Modularis Uro Plus (table) and Arcadis NUW -- 2 2005 Varic (C-arm) or Siremobil Compact L (C-arm), all products manufactured by Siemens Medical Solutions, Inc .; and the ECG Monitor Infinity Gamma (ECG) manufactured by Draeger Medical systems, Inc. These components have each been cleared for distribution in the U.S.
Due to the limited information in the provided text, a full and detailed description of acceptance criteria and a study proving the device meets them cannot be generated for all aspects. However, I can extract and infer what is available.
The provided text describes a 510(k) summary for the LithoGold extracorporeal shock wave lithotripsy (ESWL) device. The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove efficacy against pre-defined acceptance criteria in the same way a PMA study might.
Here's an attempt to answer your request based on the provided text:
Acceptance Criteria and Study for LithoGold
The primary "acceptance criteria" for a 510(k) device like LithoGold are to demonstrate substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness. The study described focuses on achieving this substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from 510(k) Process) | Reported Device Performance (LithoGold) |
|---|---|---|
| Intended Use | Fragment urinary stones in kidney (renal pelvis/calyces) and ureter (upper, middle, lower). | Meets: The LithoGold is intended to fragment urinary stones in the kidney (renal pelvis and calyces) and ureter (upper, middle and lower). |
| Technological Characteristics | Similar design features to predicate device (electrohydraulic method, ECG gating/fixed frequency). | Meets: "Both the LithoGold and the predicate device have similar technical design features..." "The LithoGold employs an electrohydraulic method of shock wave generation with both ECG gating and fixed frequency capabilities." |
| Safety and Effectiveness | Safety and effectiveness outcomes substantially equivalent to predicate lithotripsy devices. | Meets: "The confirmatory clinical study showed that the LithoGold ESWL system is expected to treat patients with renal or ureteral calculi with safety and effectiveness outcomes substantially equivalent to those for predicate lithotripsy devices." |
| Acoustic Qualities | Conformity to IEC 61846 "Ultrasonics - Pressure pulse lithotripters - Characteristics of fields" (1998). | Meets: "The LithoGold acoustic qualities have been measured using the methodology described in the consensus standard IEC 61846..." |
| Electrical and EMC Testing | Conformity to recognized consensus standards. | Meets: "...the device has been found to conform to recognized consensus standards for electrical and EMC testing." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The text only mentions "The confirmatory clinical study." It does not provide the number of patients or cases included in this study.
- Data Provenance: Not explicitly stated. It is a "confirmatory clinical study," which generally implies a prospective study conducted for regulatory submission. The country of origin is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text. For a lithotripsy device, "ground truth" often relates to stone fragmentation success or clearance, which would typically be assessed by treating physicians and follow-up imaging. However, the details of how this was established are absent.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, and the effect size of how much human readers improve with AI vs without AI assistance
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is an ESWL device for stone fragmentation, not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of "human readers improve with AI" is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable as the LithoGold is a medical device for treatment, not an algorithm. Its performance is evaluated on its ability to fragment stones, a function directly delivered by the device in conjunction with human operation.
7. The Type of Ground Truth Used
The "ground truth" implicitly referred to in the clinical study is the safety and effectiveness outcomes for treating patients with renal or ureteral calculi. This would typically involve clinical outcomes data such as:
- Stone fragmentation success (e.g., size reduction, number of fragments)
- Stone clearance rates
- Complications/adverse events
These outcomes would be assessed by clinical examination, imaging studies (e.g., X-ray, ultrasound), and patient follow-up.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device in the same way it would be for an AI algorithm. The LithoGold is a hardware device. Its design and manufacturing processes are likely informed by engineering principles, bench testing, and potentially prior clinical experience with similar devices, but not a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set was Established
As the concept of a "training set" is not applicable, the method for establishing its "ground truth" is also not applicable.
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Section 5: 510(k) Summary
Tissue Regeneration Technologies Sponsor: 110 Arnold Mill Park. Suite 400 Woodstock, Georgia 30188
Manufacturer: MTS Europe GmbH Robert-Bosch-Str. 18 D-78467 Konstanz, Germany
- Contact: Cherita James M Squared Associates, Inc 719 A Street. NE Washington, DC 20002 Ph: 202-546-1262 Ext 257 Fax: 202-546-3848
Date of submission: July 21, 2006
Proprietary Name: LithoGold
Common name: Extracorporeal shock wave lithotriptor
Recommended classification regulation: 876.5990
Class: Il
Panel: Gastroenterology/Urology Devices
Product Code: LNS
Intended Use: The LithoGold is an extracorporeal shock wave lithotripsy device intended to fragment urinary stones in the kidney (renal pelvis and calyces) and ureter (upper, middle and lower).
Predicate device: HealthTronics LithoTron (P970019)
Device description: The LithoGold is an extracorporeal shock wave therapy device designed for the non-invasive fragmentation of urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle and lower ureter). The LithoGold employs an electrohydraulic method of shock wave generation with both ECG gating and fixed frequency capabilities.
The LithoGold unit will be combined with the Modularis Uro Plus (table) and Arcadis
NUW -- 2 2005
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Varic (C-arm) or Siremobil Compact L (C-arm), all products manufactured by Siemens Medical Solutions, Inc .; and the ECG Monitor Infinity Gamma (ECG) manufactured by Draeger Medical systems, Inc. These components have each been cleared for distribution in the U.S.
Summary of non-clinical testing: Testing in accordance with "Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotribters Indicated for the Fragmentation of Kidney and Ureteral Calculi (2000)" has been successfully completed. The LithoGold acoustic qualities have been measured using the methodology described in the consensus standard IEC 61846 "Ultrasonics - Pressure pulse lithotripters - Characteristics of fields" (1998). Additionally, the device has been found to conform to recognized consensus standards for electrical and EMC testing.
Summary of clinical testing:
The confirmatory clinical study showed that the LithoGold ESWL system is expected to treat patients with renal or ureteral calculi with safety and effectiveness outcomes substantially equivalent to those for predicate lithotripsy devices.
Basis for Substantial Equivalence: Both the LithoGold and the predicate device have similar technical design features and indications for use. Bench testing and clinical testing confirm the substantial equivalence of the LithoGold to the LithoTron extracorporeal shock wave delivery system.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three swooping lines representing the human form. The symbol is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Tissue Regeneration Technologies, Inc. c/o Ms. Cherita James Regulatory Consultant M Squared Associates, Inc. 719 A Street, N.E. WASHINGTON DC 20002
NOV - 2 2006
Re: K062081
Trade/Device Name: LithoGold Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: LNS Dated: September 12, 2006 Received: September 13, 2006
Dear Ms. James:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bootion of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encready to regary and of the Medical Device Amendments, or to devices that prov to May 20, 1770, the onecations and the provisions of the Federal Food, Drug, and Cosmetic tiale occh roolabilited in are approval of a premarket approval application (PMA). You may, Act (free) market the device, subject to the general controls provisions of the Act. The general therefore, mance the det include requirements for annual registration, listing of devices, good controls provisions or allabeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket IT your device is olashiba (500 acorry) and controls. Existing major regulations affecting your Apployal), it thay be sabject to Jack aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA ate roo bat of rither announcements concerning your device in the Federal Register.
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moting Public J
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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 ($1 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:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C Hodgon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Finclosure
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Indications for Use
X062081
510(k) Number (if known): not yet assigned
Device Name: LithoGold
Indications For Use: The LithoGold is an extracorporeal shock wave lithotripsy device intended to fragment urinary stones in the kidney (renal pelvis and calyces) and ureter (upper, middle and lower).
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy broadon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K062081
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§ 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.”)