(31 days)
The Fresenius Stay Safe® Cap is intended to be used for closure of the stay safe peritoneal dialysis connectology system.
The Fresenius Sterile Stay Safe® Cap is a modified version of the Fresenius Stay Safe® Cap. The modification is the cap is now sterile.
The provided text is a 510(k) summary for the Fresenius Sterile Stay Safe® Cap. It establishes substantial equivalence to a predicate device and notes a change in sterility. However, it does not contain the detailed information required to answer your specific questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth for a performance study.
This document is a regulatory submission focused on demonstrating equivalence and safety, not on providing the results of a specific performance study in the way you've outlined. Therefore, I cannot extract the requested information from the given text.
Here's why and what's missing:
- Acceptance Criteria & Reported Performance: The document states "testing of the Fresenius Sterile Stay Safe Cap indicates that the sterile cap is safe and effective for its intended use" (page 2, Section F). However, it does not specify what tests were conducted, what the acceptance criteria for those tests were, or what the quantitative performance results were.
- Sample Size (Test Set) & Data Provenance: This information is not present.
- Number of Experts & Qualifications: This information is not present.
- Adjudication Method: This information is not present.
- MRMC Comparative Effectiveness Study: There is no mention of a comparative effectiveness study involving human readers or AI. The submission is about a physical medical device (cap).
- Standalone Performance: While it mentions "testing," it does not specify if this was a standalone algorithm performance study (which would be irrelevant for a cap). It's likely referring to physical sterility, integrity, and compatibility testing.
- Type of Ground Truth: Not applicable in the context of device performance as usually understood for AI/diagnostic devices. For a cap, "ground truth" would relate to its physical properties meeting specifications.
- Sample Size (Training Set): Not applicable, as this is a physical device, not an AI/machine learning model that requires a training set.
- Ground Truth for Training Set: Not applicable for the same reason as above.
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K083542
CONFIDENTIAL 1 of 3
Fresenius Medical Care
Fresenius Sterile Stay Safe® Cap 510(k) Summary
DEC 2 9 2008
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
A. Submitter's Information:
| Name: | Fresenius Medical Care North America |
|---|---|
| Address: | 920 Winter StreetWaltham, MA 02451 |
| Phone: | 1-781-699-4475 |
| Fax: | (781) 699-9635 |
| Contact Person: | Janet C. Kay, RAC, Director of Regulatory Affairs |
| Date of Preparation: | 25 November, 2008 |
B. Device Name:
| Trade Name: | Fresenius Sterile Stay Safe® Cap |
|---|---|
| Common/Usual Name: | Set, Administration, for Peritoneal Dialysis,Disposable |
| Classification: | Class II 876.5630 |
| ProductCode/Classification Panel | 78KDJ/Gastroenterology-Urology |
Fresenius Medical Care North America
Corporate Headquarters: 920 Winter Street Waltham, MA 02451 (781) 699-9000
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K083542
2古3
CONFIDENTIAL
Fresenius Medical Care
Fresenius Sterile Stay Safe® Cap 510(k) Summary
C. Predicate Device Name:
The Fresenius Stay Safe® Cap is a modified version of the Fresenius Stay Safe Cap was cleared under the following premarket notifications:
Fresenius Stay Safe® Cap
- . #K921818 (3/28/94);
D. Indications for Use/Intended Use:
The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe® Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows:
Indications for Use
Fresenius Sterile Stay Safe® Cap is intended to be used for closure of the stay safe peritoneal dialysis connectology system
E. Substantial Equivalence:
1. Is the product a device?
YES - The Fresenius Stay Safe® cap is a device pursuant to 21 CFR §201 [321] (h).
Fresenius Medical Care North America
Corporate Headquarters: 920 Winter Street Waltham, MA 02451 (781) 699-9000
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Image /page/2/Picture/0 description: The image contains the logo for Fresenius Medical Care. The logo consists of a stylized triangle shape with horizontal lines inside, positioned above the text "Fresenius Medical Care". The text is in a simple, sans-serif font and is left-aligned.
CUNFIDENTI
Fresenius Sterile Stay Safe® Cap 510(k) Summary
2. Does the new device have the same intended use?
YES - The intended use for the Fresenius Sterile Stay Safe® Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows:
Fresenius Sterile Stay Safe® Cap - Intended Use
Fresenius Sterile Stay Safe® Cap is intended to be used for closure of the stay safe peritoneal dialysis connectology system
Fresenius Stay Safe® Cap - Intended Use
Fresenius Sterile Stay Safe® Cap is intended to be used for closure of the stay safe peritoneal dialysis connectology system
3. Does the device have technological characteristics that raise new types of safety or effectiveness questions?
NO - The Fresenius Stay Safe® Cap is a modified version of the Fresenius Stay Safe® Cap. The modification is the cap is now sterile. The technological characteristics of the Fresenius Sterile Stay Safe® Cap are equivalent to those of the Fresenius Stay Safe® Cap and raise no new types of safety or effectiveness questions.
4. Does descriptive or performance information demonstrate equivalence?
YES - Fresenius Medical Care North America believes that the information provided in this submission clearly describes the Fresenius Sterile Stay Safe® Cap and demonstrates that it is substantially equivalent to the Fresenius Stay Safe® Cap.
F. Safety Summary
The Fresenius Sterile Stay Safe® Cap is substantially equivalent in construction, design, materials, and intended use to the commercially available Fresenius Stay Safe Cap. In addition, testing of the Fresenius Sterile Stay Safe Cap indicates that the sterile cap is safe and effective for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three bars representing the department's three main goals: health, human services, and well-being. The logo is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 9 2008
Janet C. Kay. RAC Director of Regulatory Affairs Fresenius Medical Care North America 920 Winter Street WALTHAM MA 02451
Re: K083542
Trade/Dovice Name: Fresenius Sterile Stay Safe® Cap Regulation Number: 21 CFR 8876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: KDJ Dated: November 25, 2008 Received: November 28, 2008
Dear Ms. Kay:
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 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.
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Page 2
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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
Sincerely yours.
Jorgu M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Fresenius Sterile Stay Safe® Cap "Special" 510(k) Premarket Notification
Device Name:
Fresenius Sterile Stay Safe® Cap
Indications for Use:
The Fresenius Stay Safe® Cap is intended to be used for closure of the stay safe peritoneal dialysis connectology system.
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
.
OR
Over-The-Counter Use
Fresenius Medical Care North America
Colas fehard (acting)
Corporate Headquarters: 920 Winter Street Waltham, MA 02451 (781) 699-9000
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K083542 |
|---|---|
| --------------- | --------- |
§ 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.