(90 days)
Not Found
No
The description focuses on mechanical control of irrigation flow and does not mention any computational or learning capabilities.
Yes.
The device is used for irrigation during "therapeutic and diagnostic ureteroscopy and/or endoscopic procedures," indicating its involvement in therapeutic interventions. Also, one of the functions of the device is to free up the other hand for "stone extraction, lithotripsy, or biopsy," which are all therapeutic procedures.
No
The device is intended for irrigation during therapeutic and diagnostic procedures, but its primary function is irrigation, not diagnostic analysis or imaging.
No
The device description clearly describes a physical system with a valve assembly designed for controlled irrigation, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the irrigation of the ureter and renal pelvis during therapeutic and diagnostic ureteroscopy and/or endoscopic procedures. This is a procedure performed directly on a patient's body, not on a sample taken from the body.
- Device Description: The device is an irrigating system designed for controlled irrigation through an endoscope. This is a physical device used during a medical procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of this device and its intended use do not involve the analysis of such specimens.
Therefore, this device falls under the category of a medical device used for a surgical/endoscopic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for use in the irrigation of the ureter and renal pelvis during therapeutic and diagnostic ureteroscopy and/or endoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
78 LJH
Device Description
The I.V. Piggyback Irrigating System is designed with a releasably mounted modular endoscope valve assembly. It is designed for controlled irrigation through an endoscope during urological and/or endoscopic procedures. The design of the valve allows the irrigation to be controlled between the finger and the thumb of the hand holding the endoscope, leaving the other hand completely froe for stone extraction, lithotripsy, or biopsy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ureter and renal pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals, clinics, laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative performance testing was done, between the proposed Piggyback Irrigating System and the current C.R. Bard Syringe Assist Irrigation System. Data summaries and results from the testing are included in Table 1. A biocompatibility assessment was performed on the materials with satisfactory results. Test results are included in Appendix B.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flow Rate:
- Piggyback Irrigating System: - 4 foot head height = 9.8 L/hr, - 6 foot head height = 12.0 L/hr, - 6 foot head height = 14.4 L/hr (with pressure cuff)
- C.R. Bard Syringe Assist Irrigation System: - 4 foot head height = 14.7 L/hr, - 6 foot head height = 17.8 L/hr, - 6 foot head height = 22.9 L/hr (with pressure cuff)
Plunger activation:
- Piggyback Irrigating System: 0.76 lbf
- C.R. Bard Syringe Assist Irrigation System: 3.99 lbf
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
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Confidential Kosin Technologies, LLC Piggyback Irrigating System Abbreviated 510(k)
APR 1 5 2004
K040094
Page 1 of 2
Section II
510(k) SUMMARY
| Submitted by: | Kosin Technologies, LLC.
3305 Greyfox Drive
Valparaiso, IN 46383
Phone: (219) 508-3419 |
|----------------------|-------------------------------------------------------------------------------------------------|
| | Small Business Decision No.: SBD047023 |
| | Expires: Sep, 30, 2004 |
| | Payment Identification No.: 012216-956733 |
| Contact Person: | Avtar S. Dhindsa, M.D. |
| Date Prepared: | January 14, 2004 |
| Proprietary Name: | Piggyback Irrigating System |
| Common Name: | Endoscope Irrigation Tubing Set |
| Classification Name: | Endoscope And/Or Accessories |
| Predicate Device: | C.R. Bard Syringe Assist Irrigation
510(k) #K905102 |
Description of the Device:
The I.V. Piggyback Irrigating System is designed with a releasably mounted modular endoscope valve assembly. It is designed for controlled irrigation through an endoscope during urological and/or endoscopic procedures. The design of the valve allows the irrigation to be controlled between the finger and the thumb of the hand holding the endoscope, leaving the other hand completely froe for stone extraction, lithotripsy, or biopsy.
Intended Use of the Device:
The device is intended for use in the irrigation of the ureter and renal pelvis during therapeutic and diagnostic ureteroscopy and/or endoscopic procedures.
Technological Characteristics:
The Piggyback Irrigating System is substantially equivalent to the Bard Syringe Assist Irrigation under 510(k) number K905102. It has the same intended use, and is manufactured from similar biocompatible materials as the predicate device.
Performance Data:
Comparative performance testing was done, between the proposed Piggyback Irrigating System and the current C.R. Bard Syringe Assist Irrigation System. Data summaries and results from the testing are included in Table 1.
A biocompatibility assessment was performed on the materials with satisfactory results. Test results are included in Appendix B.
1
K04 oc 94
Page 2 of 2
Section II continued
| | Kosin
Piggyback Irrigating System | C.R. Bard
Syringe Assist Irrigation
System |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Uses | This device is intended for use in
the irrigation of the ureter and
renal pelvis during the
therapeutic and diagnostic
ureteroscopy/ureteropyescopy.
Once the valve assembly is
mounted to the endoscope, the
physician can manually control
the flow of irrigation fluid during
urological and/or endoscopic
procedures. | This device is intended for use in
the irrigation of the ureter and
renal pelvis during the
therapeutic and diagnostic
ureteroscopy/ureteropyescopy. It
is connected to the endoscope
with standard luer adapters. |
| Users | Hospitals, clinics, laboratories | Hospitals, clinics, laboratories |
| Materials | Polycarbonate, nylon, PVC,
thermoplastic elastomer, silicone
rubber, stainless steel | Natural Rubber Latex,
polycarbonate, PVC, lubricant |
| Lubricant
composition | Medical grade silicone | Medical grade silicone |
| Sterility Assurance
Level | 10-6 SAL | 10-6 SAL |
| Packaging material | Tyvek pouch | Tyvek pouch |
| Modes of irrigation | 1. Continuous by gravity
2. Intermittent by depressing
plunger | 1. Continuous by gravity
2. Intermittent by depressing
plunger |
| Flow Rate | - 4 foot head height = 9.8 L/hr
- 6 foot head height = 12.0 L/hr
- 6 foot head height = 14.4 L/hr
(with pressure cuff) | - 4 foot head height = 14.7 L/hr - 6 foot head height = 17.8 L/hr
- 6 foot head height = 22.9 L/hr
(with pressure cuff) |
| Plunger activation | 0.76 lbf | 3.99 lbf |
| Single Use Only | Single Use | Single Use |
| Biocompatibility | Cytotoxicity
Sensitization
Irritation
Systemic Toxicity | Same |
| Sterilization method | Gamma | EtO |
:
Table 1. Device Comparison Information - Similarities and Differences
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract eagle design with three curved lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 2004
Avtar S. Dhindsa, M.D. Kosin Technologies, LLC 3305 Greyfox Drive VALPARAISO IN 46383
Re: K040094
Trade/Device Name: Piggyback Irrigating System Regulation Number: None Regulatory Class: Unclassified Product Code: 78 LJH Dated: January 14, 2004 Received: January 16, 2004
Dear Dr. Dhindsa:
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 (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.
3
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nonitiation. The I Dry intelligence 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 rr you the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the 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/dsma/dsmamain.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
4
K0400094
Confidential Kosin Technologies, LLC Piggyback Irrigating System Abbreviated 510(k)
Section V
INDICATIONS FOR USE STATEMENT
510(k) Number:
Piggyback Irrigating System
Device Name:
Indications For Use:
The device is intended for use in the irrigation of the ureter and renal pelvis during therapeutic and diagnostic ureteroscopy and/or endoscopic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRII, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR §801.109)
Over-The-Counter Use__
Nancy C. Hogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number