(224 days)
The Fresenius CAPD stay.safe® Disposable Administration Sets with stay•safe® Connector is indicated for use in end stage acute and chronic renal disease.
The Fresenius CAPD stay•safe® Disposable Administration Sets with stay•safe® Connector consists of a circular housing designed with three, evenly spaced, outlet ports. Individual ports specifically provide for attachment either to the patient, to the peritoneal dialysis solution, or to a drain bag. The outlet port plugs allow the start or stop of solution flow; and prior to use the outlet port for the patient connection is covered with a cap. A knob is turned to different positions to initiate the various treatment steps of the peritoneal dialysis procedure.
The provided text is a 510(k) summary for a medical device called "Fresenius CAPD stay•safe® Disposable Administration Sets with stay•safe® Connector." 510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria and detailed performance metrics as might be found in a Premarket Approval (PMA) application.
Based on the provided text, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Met ISO 10993-1 biological requirements for safety screening of materials in indirect contact for greater than 30 days. |
| Pyrogenicity | Tested to a Limulus Amebocyte Lysate (LAL) specification of 0.01 EU/mL. (Implies meeting this specification) |
| Sterility | Sterilized by a method determined and verified to assure an SAL of ≥ 10⁻⁶. (Implies achieving this sterility assurance level) |
| Functional and Physical Properties | Performed prior to product release. (Implies successful completion of these tests.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states "Clinical Data: Not Applicable." The data provenance for the non-clinical tests (biocompatibility, pyrogenicity, sterility, functional/physical) is not specified. It can be inferred that these tests were conducted by the manufacturer, Fresenius Medical Care North America (headquartered in Lexington, MA). The retrospective or prospective nature of these tests is not mentioned, but they are typically conducted as part of the product development and manufacturing process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The study did not involve human interpretation or subjective measurements that would require expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical study involving human interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a disposable administration set, not an AI-assisted diagnostic or interpretive tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by established scientific standards and specifications:
- Biocompatibility: ISO 10993-1 standards.
- Pyrogenicity: LAL specification of 0.01 EU/mL.
- Sterility: Sterility Assurance Level (SAL) of ≥ 10⁻⁶.
- Functional and Physical Testing: Internal product release specifications.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an algorithm or AI-based device.
9. How the ground truth for the training set was established
Not applicable, as there was no training set.
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page 1 of 2
510 (k) Summary
MAR 0 5 2003
| Applicant: | Fresenius Medical Care North America | |
|---|---|---|
| Contact: | Arthur E. EilinsfeldDirector, Regulatory AffairsFresenius Medical Care North America95 Hayden AvenueLexington, MA 02420-9192 | Telephone: 781-402-9068Fax: 781-402-9082 |
| Trade Name: | Fresenius CAPD stay•safe® Disposable Administration Setswith stay•safe® Connector | |
| Common Name: | Disposable Connector and Tubing Set for Solution Deliveryduring Peritoneal Dialysis | |
| Classification Name: | Peritoneal Dialysis System and Accessories per 21CFR876.5630 | |
| Equivalence Predicate: | CAPD Safe-Lock™ Transfer Sets with Pre-filled Connector | |
| Device Description: | The Fresenius CAPD stay•safe® Disposable AdministrationSets with stay•safe® Connector consists of a circularhousing designed with three, evenly spaced, outlet ports.Individual ports specifically provide for attachment either tothe patient, to the peritoneal dialysis solution, or to a drainbag. The outlet port plugs allow the start or stop of solutionflow; and prior to use the outlet port for the patientconnection is covered with a cap.A knob is turned to different positions to initiate the varioustreatment steps of the peritoneal dialysis procedure. | |
| Statement ofIntended Use: | The Fresenius CAPD stay•safe® Disposable AdministrationSets with stay•safe® Connector are disposable devices forsingle use. The areas under protective guards and the fluidpathway are sterile and non-pyrogenic. The devicescontinue to be restricted to the sale by or on the order of aphysician. |
Fresenius Medical Care North America
Corporate Headquarters: 95 Hayden Avenue Lexington, MA 02420-9192
Fresenius CAPD stay•safe® Disposable Administration Sets with stay•safe® Connector
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Page 2 of 2
510 (k) Summary
It is indicated for use in patients with end-stage acute and Statement of Indications for Use: chronic renal disease.
- Summary of In general, the design and materials of the subject devices Technological are the same as the Fresenius predicate devices. The materials have been tested to ISO10993 and are shown not Differences: to raise any different issues regarding safety and effectiveness. A hazard analysis determination indicates that the design differences do not impact the safety or effectiveness of the device; and that the differences are not critical to the intended therapeutic use of the device.
Clinical Data: Not Applicable
Conclusions: Components of the proposed devices have met the ISO 10993-1 biological requirements for safety screening of materials in indirect contact for greater than 30 days. The sets are tested to a Limulus Amebocyte Lysate (LAL) specification of 0.01 EU/mL. Sets are sterilized by a method determined and verified to assure an SAL of ≥ 10°. Functional and physical testing is performed prior to product release.
Arthur E. Eilinsfeld
Director, Fresenius Regulatory Affairs
7/18/02
Date
K0224/2
Premarket Notification 510 (k) Number
Premarket Notification 510 (k) Number
AEE:dmk
Fresenius Medical Care North America
Corporate Headquarters: 95 Hayden Avenue Lexington, MA 02420-9192
Fresenius CAPD stay.safe® Disposable Administration Sets with stay.safe® Connector
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 5 2003
Mr. Arthur E. Eilinsfeld Director, Regulatory Affairs Fresenius Medical Care North America 95 Hayden Avenue LEXINGTON MA 02420-9192
Re: K022412
Trade/Device Name: Fresenius CAPD stay •safe® Disposable Administration Sets with stay safe® Connector Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: 78 KDJ Dated: December 3, 2002 Received: December 5, 2002
Dear Mr. Eilinsfeld:
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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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 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:
| 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 Crogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Device Name:
Fresenius CAPD stay•safe® Disposable Administration Sets with stay•safe® Connector
Indications for Use:
The Fresenius CAPD stay.safe® Disposable Administration Sets with stay•safe® Connector is indicated for use in end stage acute and chronic renal disease.
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
Nancy Brogdon
(Division Sign-Off Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022412
Fresenius Medical Care North America
Corporate Headquarters: 95 Hayden Avenue Lexington, MA 02420-9192
Fresenius CAPD stay.safe® Disposable Administration Sets with stay.safe® Connector
§ 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.