(85 days)
Not Found
No
The device description explicitly states "The device has no Software control" and there are no mentions of AI, DNN, or ML in the provided text.
Yes
The device is described as an "Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment," which directly treats a medical condition.
No
The device description clearly states its purpose is for "urinary stones treatment" and "to fragment urinary stones," which describes a therapeutic function, not a diagnostic one.
No
The device description explicitly states "The device has no Software control" and describes physical hardware components like a Shock Wave Generator and Urological Table.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Integra SL Function: The Integra SL is an Extracorporeal Shock Wave Lithotripter (ESWL). Its purpose is to fragment urinary stones within the body using shock waves. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states it's for "fragment[ing] urinary stones in the kidney... and upper ureter." This is a treatment, not a diagnostic test.
- Device Description: The description details a physical device that generates shock waves and is used in conjunction with imaging modalities to target stones inside the body. There is no mention of analyzing biological samples.
The Integra SL is a therapeutic medical device used for treating a specific condition, not for diagnosing or monitoring a condition through the analysis of in vitro samples.
N/A
Intended Use / Indications for Use
Integra SL is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter.
Product codes (comma separated list FDA assigned to the subject device)
78 LNS
Device Description
Integra SL is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment. The device consists of a Shock Wave Generator (SWAG), a Urological Table (UT) and the remote controls. Integra SL also contains the necessary interfaces for fluoroscopic and (or) ultrasonic imaging devices. The device has no Software control.
Integra SL includes the following features:
- EM Shockwave generator with parabolic reflector for focusing mechanism
- Swinging reflector (i.e. shockwaves are produced by angularly moving the shockwave while keeping the Therapeutic focus (F2) at the stone such that the shockwaves converge on the stone from multiple orientations).
- A stand alone UT unit
- Modular construction
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic and (or) ultrasonic imaging devices
Anatomical Site
kidney (renal pelvis and renal calyces) and upper 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
No clinical tests were performed
Description of the test set, sample size, data source, and annotation protocol
No clinical tests were performed
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Integra SL was tested according to the following standards:
- IEC 60601-1 (1988) +A1 (1991) +A2 (1995) .
- IEC 60601-1-1 (2000) .
- IEC 60601-1-2 (2001) .
- . IEC 606001-2-36 (1997)
- . IEC 61846 (1998)
- IEC 60601-2-46 (1998) .
- ANSI/ AAMI/ ISO 10993– 1 (1998) .
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
SECTION 5 - 510(k) SUMMARY KC62147
[Submitted pursuant to 21 CFR 807.92(a). All data included in this document are accurate and complete to the best of DSC's knowledge.]
1. Submitter Information
OCT 2 0 2006
| Submitter: | | Direx Systems Corporation
437 Turnpike Street
Canton
MA 02021 |
|--------------------------------|--|------------------------------------------------------------------------|
| Telephone: | | (339) 502-6013 |
| Fax: | | (339) 502-6018 |
| Contact Person | | Larisa Gershtein
QA Manager |
| Contact Person e-mail address: | | lgershtein@direxusa.com |
| 2. Device | | |
| Trade/Proprietary Name: | | Integra SL |
| Common/Usual Name: | | Extracorporeal Shock Wave Lithotripter |
| Regulation Number: | | 21 CFR 876.5990 |
| Trade/Proprietary Name: | Integra SL |
|---|---|
| Common/Usual Name: | Extracorporeal Shock Wave Lithotripter (ESWL |
| Regulation Number: | 21 CFR 876.5990 |
| Regulatory Class: | Class II (special controls) |
| Product code: | 78 LNS |
| Panel: | Gastroenterology and Urology |
3. Predicate Devices
Direx Integra (K053640) Direx Tripter X - 1 Compact Duet (K041582)
1
4. Intended Use:
Integra SL is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter.
5. Description
Integra SL is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment. The device consists of a Shock Wave Generator (SWAG), a Urological Table (UT) and the remote controls. Integra SL also contains the necessary interfaces for fluoroscopic and (or) ultrasonic imaging devices. The device has no Software control.
Integra SL includes the following features:
-
EM Shockwave generator with parabolic reflector for focusing mechanism
-
Swinging reflector (i.e. shockwaves are produced by angularly moving the shockwave while keeping the Therapeutic focus (F2) at the stone such that the shockwaves converge on the stone from multiple orientations).
- ▷ A stand alone UT unit
-
Modular construction
6. Clinical Tests
No clinical tests were performed
7. Performance Testing
Integra SL was tested according to the following standards:
- IEC 60601-1 (1988) +A1 (1991) +A2 (1995) .
- IEC 60601-1-1 (2000) .
- IEC 60601-1-2 (2001) .
- . IEC 606001-2-36 (1997)
- . IEC 61846 (1998)
- IEC 60601-2-46 (1998) .
- ANSI/ AAMI/ ISO 10993– 1 (1998) .
2
- 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
7. Substantial Equivalence
Integra SL is 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, Integra.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Larisa Gershtein QA Manager Direx Systems Corp. 437 Turnpike Street CANTON MA 02021
OCT 2 0 2006
Re: K062147
Trade/Device Name: Integra SL Regulation Number: 21 CFR 876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: LNS Dated: September 21, 2006 Received: September 22, 2006
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.
Image /page/3/Picture/10 description: The image is a circular seal or logo. The text "1906-2006" is at the top of the seal. The letters "PA" are in the center of the seal in a bold font. The word "Centennial" is below the letters. Three stars are below the word "Centennial".
Protecting and Promoting Public Health
4
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 (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:
| 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. Hogdon
Nancy C. B rogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2 -
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Image /page/5/Picture/0 description: The image shows the logo for Direx Systems Corp. The logo is in black and white and features the word "DiREX" in large, bold letters. Below the word "DiREX" is a horizontal line, and below that is the text "SYSTEMS CORP." in smaller letters. The "X" in "DiREX" is stylized with two intersecting lines.
Section 4: Indications for Use Statem
Indications for Use STATEMENT
510(k) Number (if known): K6Ce 2147
Device Name:
Integra SL
Indications for Use:
Integra SL is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter
Prescription Use
(Per 21 CFR § 801.109)
OR
Over the Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Syverson
Division Sign Off
Division Sign-Off Division of Reproductive, Abdomin and Radiological Device 510(k) Number
437 Turnpike Street ◆ Canton, MA 02021 Phone: (339) 502-6013 ♦ Fax: (339) 502-6018 e - m a i l p r o m o @ d i r e x u s a . c o m