(64 days)
The intended use of the Tripter-X1 Compact Extracorporeal Shock Wave Lithotripter is the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).
The Compact is a transportable Electrohydraulic Extracorporeal Shock Wave Lithotripter, which consists of a Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and control means.
The provided document is a 510(k) summary for the Tripter X-1 Compact Extracorporeal Shock Wave Lithotripter with a Sonographic Localization Option. It explicitly states that no clinical tests were performed (Section 7, "Clinical Tests").
Therefore, the following information cannot be extracted from the provided text:
- Table of acceptance criteria and the reported device performance: No acceptance criteria or performance data from clinical or standalone studies are mentioned.
- Sample size used for the test set and the data provenance: No test set data is mentioned.
- Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth establishment for a test set is mentioned.
- Adjudication method for the test set: No adjudication method is mentioned.
- Multi Reader Multi Case (MRMC) comparative effectiveness study, including effect size: No MRMC study was performed.
- Standalone (algorithm only) performance: This device is a medical device (lithotripter), not an AI algorithm, so standalone performance in that context is not applicable. Even if it were, no performance studies were conducted.
- Type of ground truth used: Not applicable as no studies were performed.
- Sample size for the training set: Not applicable as no AI/algorithm training is mentioned for this device.
- How the ground truth for the training set was established: Not applicable as no AI/algorithm training is mentioned.
The submission claims that "The Compact with the Sonographic Localization Option meets the requirements for a special 510(k) by the virtue of being a minor modification, which does not change the fundamental technology or reduce safety and effectiveness, of the Company's predicate device, the Tripter X-1 Compact." This implies that its acceptance criteria were met by demonstrating substantial equivalence to predicate devices without the need for new clinical performance studies.
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APR 2 8 2004
SECTION 6 - 510(k) SUMMARY
K040470
Page 1 of 2
[Submitted pursuant to 21 CFR 807.87(h)]
1. Submitter Information
| Submitter: | Direx Systems Corporation11 Mercer RoadNatick Business ParkNatick, MA 01760 |
|---|---|
| Telephone:Fax:Contact Person | (508) 651-0900(508) 651-8125Larisa GershteinQA Manager |
| Contact Person e-mail address: | lgershtein@direxusa.com |
| 2. Device | |
| Trade/Proprietary Name: | Tripter X-1 Compact (to be marketed as"Compact") w. Sonographic LocalizationOption |
| Common/Usual Name: | Extracorporeal Shock Wave Lithotripter(ESWL) |
| Classification Name/ Product code: | 78 LNS |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 876.5990 |
3. Predicate Devices
Tripter-X1 Series Lithotripters (Tripter-X1 and Tripter -X1 Compact): P-920034 Tripter X1 Compact Duet: K023535 Ipu Rx-2 Image processing unit, Radiology K964327 Dornier CompactS / Compact Delta: P840008/S56 Dornier Compact Alpha: K002929 (and K011873) SONOLITH 3000 PMA: P880011
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Coyh. 242
4. Intended Use:
The intended use of the Tripter-X1 Compact Extracorporeal Shock Wave Lithotripter is the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).
5. Technological Characteristics:
This Compact includes a sonographic localization option that enables the use of ultrasound for positioning. The device has the same fundamental scientific technology and intended use as predicate devices.
6. Description
The Compact is a transportable Electrohydraulic Extracorporeal Shock Wave Lithotripter, which consists of a Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and control means.
7. Clinical Tests
No clinical tests were performed.
8. Conclusion
The Compact with the Sonographic Localization Option meets the requirements for a special 510(k) by the virtue of being a minor modification, which does not change the fundamental technology or reduce safety and effectiveness, of the Company's predicate device, the Tripter X-1 Compact.
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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" written around it. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with three curved lines above it, representing care and concern for the health and well-being of the nation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2004
Ms. Larisa Gershtein QA Manager DiREX Systems Corporation 11 Mercer Road NATICK MA 01760
Re: K040470
Trade/Device Name: Tripter-X1 Compact Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: 78 LNS Dated: April 1, 2004 Received: April 5, 2004
Dear Ms. Gershtein:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have a rowe a your 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, listing 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 (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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The PDA mailing or casonalism 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 If you desire specific advice for your dones on one of the following numbers, based on the regulation number at the top of the 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 Additionally, Tor questions on the promotion = ............................................................................................................................... Othice of Compliance at (301) 33 P 1.059 Part 807.97) you may obtain. Other general by reference to prematical (Dr. It is in the Act may be obtained from the Division of Strail information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octablant Solusion of Schools of Schildsmaldsmamain.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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Image /page/4/Picture/0 description: The image shows the logo for Direx Systems Corp. The logo is in black and white, with the word "Direx" in large, bold letters. Below the word "Direx" is the phrase "Systems Corp." in smaller letters. The logo is simple and modern.
INTENDED USE STATEMENT
510(k) Number (if known): X04047 o
Device Name:
Tripter-X1 Compact
Intended Use:
The intended use of the Tripter-X1 Compact Extracorporeal Shock Wave Lithotripter is the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
510(k) Number K040470
Prescription Use (Per 21 CFR § 801. 109)
OR
Over the Counter Use
Daniel G. Seymann
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
11 Mercer Road ↓ Natick, Ma 01760 Phone: 1-888-TRIPTER + Fax: 508-651-8125 e - mail : p r o m o @ d i r e x u s a . c o m
§ 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.”)