(84 days)
The Fresenius StaySafe Patient Connectors are intended for use with a peritoneal cycler for drainage and infusion of PD solution during a peritoneal dialysis exchanges. The Fresenius StaySafe Patient Connectors are indicated for use in acute and chronic peritoneal dialysis.
The Fresenius StaySafe Patient Connectors are designed for use during cycler assisted peritoneal dialysis. The device incorporates a pin and push button/plunger mechanism that provides a closed system after patient disconnection. The pin engages the patient's catheter during a PAUSE or at then end of the treatment. The device also has several accessories associated with its use: StaySafe adaptors. Multiple tubing sets, and extension sets. The device is provided sterile and is for single use only.
The provided 510(k) summary for the Fresenius STAYSAFE Patient Connectors does not include specific acceptance criteria or performance data from a study as one would typically find for a new device requiring detailed performance evaluation against stated metrics. Instead, the document focuses on demonstrating substantial equivalence to predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the given document. The submission hinges on the device being "substantially equivalent" to predicate devices, implying that its performance is presumed to be similar to those already on the market without needing entirely new, quantifiable acceptance criteria or performance metrics in a table.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The submission states that substantial equivalence is supported by "information, materials data, device description, and performance testing submitted and/or described within this 510K." However, no details about specific test sets, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective) for any studies are given.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. Given that the submission focuses on substantial equivalence to predicate devices rather than a de novo performance study requiring expert ground truth establishment, this detail would likely not be relevant or present in such a summary.
4. Adjudication Method for the Test Set
This information is not provided. As no specific test sets or ground truth establishment methods are described, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done according to the provided text. The submission relies on demonstrating substantial equivalence to predicate devices, not on showing human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done according to the provided text. The device described is a physical medical connector, not an algorithm or AI system.
7. The Type of Ground Truth Used
This information is not explicitly provided. Since the device is a physical connector, "ground truth" as typically understood in data-driven AI/software contexts (pathology, outcomes data, expert consensus) is not directly applicable in the same way. The "truth" would be its adherence to design specifications, material properties, and functional performance, likely assessed through engineering and biocompatibility testing, but these details are not provided in this summary. The summary states that "materials data" and "performance testing" were submitted, implying these types of evaluations were conducted.
8. The Sample Size for the Training Set
This information is not provided. "Training set" is not relevant here as the device is a physical medical device, not an AI or machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. "Training set" is not relevant here.
Summary of what is present:
The submission focuses primarily on establishing substantial equivalence by stating that the subject device (Fresenius STAYSAFE Patient Connectors) has:
- Identical indications for use to predicate devices.
- Identical technological characteristics to predicate devices.
- Identical design features to predicate devices.
- Identical materials to predicate devices.
The document lists several predicate devices from Fresenius Medical Care itself, implying a direct comparison to previously cleared products. The performance testing and materials data mentioned are likely standard engineering and biocompatibility tests to ensure the device functions as intended and safely, consistent with its identical characteristics to predicate devices, rather than a novel study with specific acceptance criteria that are quantitatively reported in this summary.
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SEP 2 4 2004
K041792
Page 1 of 2
Fresenius STAYSAFE Patient Connectors 510(k) Premarket Notification
510K Summary
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the Fresenius STAYSAFE Patient Connectors.
| Company: | Fresenius Medical Care North America95 Hayden Ave.Lexington, MA 02420 |
|---|---|
| Date: | July 1, 2004 |
| Contact Person: | Arthur Eilinsfeld |
| Trade Name: | Fresenius STAYSAFE Patient Connectors |
| Common Name: | Disposable Peritoneal Dialysis Tubing Sets andAccessories |
| Classification Name and Reference: | 21 CFR §876.5630 Set, Administration, for PeritonealDialysis, Disposable - Class II |
| Device Product Code and Panel Code: | 78/KDJ/Gastroenterology-Urology |
| Predicate Device(s): | Fresenius AMP 80/2 Pediatric Cycler System (nowMarketed under ECO™ Peritoneal Dialysis 4 LeadPrefilled Set with Snap Disconnect) (#K811986 - SE08/31/81);Fresenius CAPD StaySafe Disposable AdministrationSets with StaySafe Connector (#K022412 - SE03/05/03);Fresenius AMP 80/2 Pediatric Cycler System (nowMarketed under ECO™ Peritoneal Dialysis 4 LeadPrefilled Set with Snap Disconnect) (#K811986 - SE08/31/81);Fresenius CAPD Safelock Transfer Set (#K904806 -SE 01/11/91);Closed Disconnect System (#K900106 SE - 07/16/90);submitted under Delmed, now owned by FreseniusMedical Care. |
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Fresenius STAYSAFE Patient Connectors 510(k) Premarket Notification
510K Summary
DEVICE INFORMATION:
A. DESCRIPTION
The Fresenius StaySafe Patient Connectors are designed for use during cycler assisted peritoneal dialysis. The device incorporates a pin and push button/plunger mechanism that provides a closed system after patient disconnection. The pin engages the patient's catheter during a PAUSE or at then end of the treatment. The device also has several accessories associated with its use: StaySafe adaptors. Multiple tubing sets, and extension sets. The device is provided sterile and is for single use only.
B. INTENDED USE
The Fresenius StaySafe Patient Connectors are intended for use with a peritoneal cycler for drainage and infusion of PD solution during peritoneal dialysis exchanges. The Fresenius StaySafe Patient Connectors are indicated acute and chronic peritoneal dialysis.
C. SUBSTANCIAL EQUIVALENCE INFORMATION
The indications for use, technological characteristics, design features, and materials are identical to the predicate devices. The STAYSAFE Patient Connectors are substantially equivalent to the predicate devices supported by the information, materials data, device description, and performance testing submitted and/or described within this 510K.
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741792
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes above a wavy line, representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 2004
Ms. Nichole Riek Regulatory Affairs Supervisor Fresenius Medical Care - North America Dialysis Products Division 95 Hayden Avenue LEXINGTON MA 02420-9192
Re: K041792
Trade/Device Name: STAYSAFE Patient Connectors Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: 78 KDJ Dated: July 1, 2004 Received: July 2, 2004
Dear Ms. Riek:
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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his ieter will anow you to ocgin mating of substantial equivalence of your device to a legally premarket nothcation. The PDF missing cation 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 If you desire specific advice to your as the following numbers, based on the regulation number at the top of the 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 Additionally, 101 questions on the promote the regulation entitled, "Misbranding Other of Complance at (2017 97 - 105 7.97) you may obtain. Other general by relevence to premarked includion (2 obtained from the Division from the Division of Small information on your responsionalist and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Sollass 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
l'age 2
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Fresenius Medical Care
Indications for Use Statement
Device Name:
Fresenius STAYSAFE Patient Connectors
Indications for Use:
The Fresenius StaySafe Patient Connectors are intended for use with a peritoneal cycler for drainage and infusion of PD solution during a peritoneal dialysis exchanges. The Fresenius StaySafe Patient Connectors are indicated for use in acute and chronic peritoneal dialysis.
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 | |
| Corporate Headquarters: | 95 Hayden Avenue Lexington, MA 02420 (781) 402-9000 |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K041792 |
000037
§ 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.