(463 days)
Peritoneal Dialysis Coil Catheter with Spi-Argent™II, for the transport of dialysate solution to and from the peritoneal cavity for treatment of renal failure; suitable for CAPD (Continuous Ambulatory Peritoneal Dialysis)
Peritoneal Dialysis Coil Catheter with Spi-Argent™II, for the transport of dialysate solution to and from the peritoneal cavity for treatment of renal failure; suitable for CAPD (Continuous Ambulatory Peritoneal Dialysis). Peritoneal Dialysis Coil Catheter with Spi-Argent™ll is the same as the Peritoneal Dialysis Coil Catheter, K850247 except for the Spi-Argent™ II option offering. Spi-Argent™ II is the same surface treatment as the K942709, Mediastinal Drain with Spi-Argent™ II. The Spi-Argent™II surface treatment provides a lubricious surface to ease insertion and removal of the catheter.
The provided text is a 510(k) summary for the Sil-Med Corporation's Peritoneal Dialysis Coil Catheter with Spi-Argent™ II. This document describes the device, its intended use, and its predicate devices for the purpose of demonstrating substantial equivalence to the FDA.
Crucially, this document does NOT contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies with acceptance criteria in the same way a PMA (Premarket Approval) submission would. While the sponsor would have conducted internal testing to ensure the device performs as intended, the provided summary does not include the specifics of such testing, acceptance criteria, or performance data.
Therefore, I cannot provide accurate answers to your questions based solely on the provided text. The requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not present in this document.
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510 (k) Summary
| Company: | Sil-Med Corporation700 Warner BoulevardTaunton, MA 02780 |
|---|---|
| Telephone:Fax: | (508) 823-7701(508) 823-1438 |
| Contact Person: | Karen K. SylviaQA/QC Manager |
| JUL 18 1997 | |
| Trade Name: | Peritoneal Dialysis Coil Catheter with Spi-Argent™I |
| Common Name: | Peritoneal Dialysis Catheter |
| Classification Name: 78 FJS Peritoneal dialysis system and accessories. (878.5630) | |
| Description: | Peritoneal Dialysis Coil Catheter with Spi-Argent™II, for the transport ofdialysate solution to and from the peritoneal cavity for treatment of renal failure;suitable for CAPD (Continuous Ambulatory Peritoneal Dialysis). |
| Predicate Device: | Peritoneal Dialysis Coil Catheter: K850247Mediastinal Silicone Drain: K942709Antimicrobial Multi-Lumen Central Venous Catheter: K900263 |
| Intended Use: | Peritoneal Dialysis Coil Catheter with Spi-Argent™II, for the transport ofdialysate solution to and from the peritoneal cavity for treatment of renal failure;suitable for CAPD (Continuous Ambulatory Peritoneal Dialysis) |
Peritoneal Dialysis Coil Catheter with Spi-Argent™ll is the same as the Peritoneal Dialysis Coil Catheter, K850247 except for the Spi-Argent™ II option offering. Spi-Argent™ II is the same surface treatment as the K942709, Mediastinal Drain with Spi-Argent™ II. The Spi-Argent™II surface treatment provides a lubricious surface to ease insertion and removal of the catheter.
Sil-Med Corporation 510(k) Number: K961392 Peritoneal Dialysis Coil Catheter with Spi-Argent™ll
Image /page/0/Picture/5 description: The image contains a circular symbol with the letter 'A' inside. The letter 'A' is stylized and appears to be handwritten. The circle surrounds the letter, creating a logo-like design. The symbol is simple and monochromatic.
Rev. 14 Apr 1997
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Image /page/1/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with a flowing design that suggests movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 1997
Ms. Karen K. Sylvia OA/OC Manager Sil-Med Corporation .. 700 Warner Boulevard Taunton, Massachusetts 02780 Re: K961392 Peritoneal Dialysis Coil Catheter with Spi-Argent™ II ... .. . .. .. Dated: May 1, 1997 Received: May 2, 1997 Regulatory class: II 21 CFR §876.5630/Product code: 78 FJS
Dear Ms. Sylvia:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/odrin/dsmamain.html".
Sincerely yours
W. Hiau Yun
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Sil-Med Corporation 700 Warner Boulevard Taunton, MA 02780 Revision Date: 14 April, 1997
510(k) Number (if known): K961392 Device Name: Peritoneal Dialysis Coil Catheter with Spi-Argent™
Indications For Use:
Peritoneal Dialysis Catheter with Spi-Argent™II surface treatment, for the transport of dialysate solution to and from the peritoneal cavity for treatment of renal failure; suitable for CAPD (Continuous Ambulatory Peritoneal Dialysis)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Roter L. Satting
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices K961392 510(k) Number .
Prescription Use レ (Per 21 CFR 801.109)
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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.