(61 days)
The intended use of the Duet SP Extracorporeal Shock Wave Lithotripter is the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).
The Duet 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 text states that no clinical tests were performed for the Duet SP Extracorporeal Shock Wave Lithotripter.
Therefore, the device did not undergo a study to prove it meets acceptance criteria, meaning there is no information available for the following points:
- A table of acceptance criteria and the reported device performance: Not applicable as no clinical tests were performed.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable.
- 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.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The submission is a "special 510(k)" based on the device being a minor modification of predicate devices, and that these modifications "do not change the fundamental technology or reduce safety and effectiveness."
Acceptance Criteria/Regulatory Basis:
The device's acceptance is based on its substantial equivalence to predicate devices (Duet K023535 and Duet SLO K041582) for the fragmentation of urinary tract stones. The modification (inclusion of a sonographic localization option) was deemed minor and not requiring new clinical data to prove safety and effectiveness.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows a handwritten text string that appears to be an identifier or code. The text reads "K05009/" with the characters written in a slightly stylized manner. The numbers are clearly distinguishable, and the forward slash at the end is also visible.
SECTION 6 -- 510(k) SUMMARY
[Submitted pursuant to 21 CFR 807.87(h)]
1. Submitter Information
| Submitter: | Direx Systems Corporation11 Mercer RoadNatick Business ParkNatick, MA 01760 |
|---|---|
| Telephone:Fax:Contact PersonContact Person e-mail address: | (508) 651-0900(508) 651-8125Larisa GershteinQA Managerlgershtein@direxusa.com |
| 2. Device | |
| Trade/Proprietary Name: | Duet SP |
| 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
Duet K023535, Duet SLO K041582, and TWINHEADS TH-101 K030346
{1}------------------------------------------------
4. Intended Use:
The intended use of the Duet SP 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 Duet 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 Duet 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 Duet 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 devices: Duet K023535 and Duet SLO K041582.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a black and white emblem. The emblem is circular and contains a stylized bird in the center. The bird is flying towards the right. The text "DEPARTEMENT OF KULTUR & KESENIAN NEGARA" is written around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 2005
Ms. Larisa Gershtein Quality Assurance Manager Direx Systems Corp. 11 Mercer Road NATICK MA 01760
Re: K050091
Koodor1
Trade/Device Name: Duet SP Extracorporeal Shock Wave Lithotripter Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: 78 LNS Dated: February 17, 2005 Received: February 22, 2005
Dear Ms. Gershtein:
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, 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 (Premarket Approval), it may be subject to such 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.
{3}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k)
. I has begin and the subserved and coloralence of your device to a lexall This letter will allow you to begin market it your device of your device of your device to a legally
premarket notification. The FDA innding of substantial equir device and premarket notification. The FDA finding of Substantial equiralifor of 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 device on our labering regaration (1 - 1 - 1
contact the Office of Compliance at one of the following numbers, based on the regulation 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 Also, please note the regulation entitled, "Misorianaling of your responsibilities under the Act from the 807.97). You may obtain other general information on your respear.
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/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): K050091
Device Name: Duet SP Extracorporeal Shock Wave Lithotripter
Indications for Use: The intended use of the Duet SP Extracorporeal Shock Wave Lithotripter is the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).
V Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Broadon
(Division Sig Division of Reproductive, Ab 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.”)