(336 days)
Medisystems Peritoneal Dialysis Set product line is indicated for use in compatible peritoneal dialysis procedures. Specific codes are indicated respectively for Continuous Ambulatory Peritoneal Dialysis (CAPD) and Cycler Peritoneal Dialysis.
The Medisystems' Peritoneal Dialysis Sets comprise a number of codes to facilitate peritoneal dialysis procedures. The Medisystems' Peritoneal Dialysis Sets consist of tubing and componentry to allow connection between a container of dialysate solution and the patient's indwelling catheter for instillation into and retention of the dialysate in the peritoneal cavity. The Peritoneal Dialysis Sets then allow exchange of fresh dialysate by providing a means to aseptically drain the used dialysate from the peritoneal cavity into a collection bag for disposal.
The provided text describes a 510(k) submission for Medisystems Peritoneal Dialysis Sets, focusing on substantial equivalence to a predicate device rather than presenting detailed performance studies or specific acceptance criteria with quantifiable metrics. The information available is primarily about the product description, intended use, and manufacturing controls.
As such, many of the requested sections (e.g., sample sizes, expert qualifications, effect size for MRMC studies, standalone performance data) cannot be fully addressed from the given document because the submission does not detail such a "study that proves the device meets the acceptance criteria" in the way one might expect for a diagnostic or AI-driven device. Instead, it relies on demonstrating equivalence through design and material characteristics, and manufacturing quality control.
Here's an attempt to structure the available information per your request, with explicit notes on what information is not present in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (as inferred/stated) | Reported Device Performance |
|---|---|---|
| Safety & Effectiveness | Meet required release specifications (sterility, pyrogenicity, physical testing, visual examination). | Device manufacturing "defined by written and approved procedures that conform to the product design specifications" and documented in "Device Master Records." All finished products are tested and must meet these specifications before distribution. (No specific performance data i.e., rates, values presented). |
| Intended Use | Identical to predicate device: exchange dialysate solution in peritoneal dialysis for kidney failure. | Stated to be identical to the predicate device. (No performance metrics given). |
| Technological Characteristics | Components for access, tubing for instillation/drainage, drain bag for aseptic collection, various codes for different needs. | Stated to be "identical to those of the predicate device." (No performance metrics given). |
| Substantial Equivalence | Equivalent to Fresenius USA's peritoneal dialysis sets. | FDA reviewed and determined the device is "substantially equivalent." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document refers to "all finished products" being tested as part of manufacturing release, implying ongoing quality control rather than a specific test set for a performance study.
- Data Provenance: Not applicable in the context of a clinical performance study. The "data" pertains to internal manufacturing test results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The ground truth for this device appears to be based on adherence to engineering and safety specifications (e.g., sterility, pyrogenicity, physical integrity), rather than expert clinical assessment of outcomes or diagnoses.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used in clinical trials or diagnostic accuracy studies where multiple human readers or AI make assessments that need to be reconciled against a ground truth. The testing described here is manufacturing quality control.
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
- No MRMC comparative effectiveness study was done or mentioned. This type of study is relevant for AI-assisted diagnostic devices, which is not the nature of this submission (a peritoneal dialysis set).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a medical accessory, not an algorithm or AI system.
7. The type of ground truth used
- The "ground truth" for this device's acceptance is based on engineering specifications and established safety standards (e.g., sterility, pyrogenicity, physical integrity as defined by written procedures and design specifications) rather than clinical outcomes, pathology, or expert consensus on a diagnostic task.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for the device involves manufacturing processes and quality control.
9. How the ground truth for the training set was established
- Not applicable. As this is not an AI/ML device, there is no "training set" or corresponding ground truth establishment in that context.
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Section I
AUG 1 5 1997
510(k) Summary Required by 21 CFR 8807.92
I. Submitter:
McKenna & Cuneo, L.L.P. A. Name: on behalf of Medisystems Corporation
- B. Address: 1900 K Street, NW Washington, DC 20006
C. Phone and Fax Numbers: Phone: 202-496-7500 Fax 202-496-7756
D. Contact Person: Mr. Larry R. Pilot
II. Date of preparation of this Summary: August 7, 1996
III. Trade Name: Medisystems Peritoneal Dialysis Sets
IV. Common Name: Peritoneal Dialysis Sets
V. Classification Name: Peritoneal Dialysis System and Accessories
VI. The Marketed Device(s) to which Equivalence is Claimed: The Peritoneal Dialysis Sets which are the subject of this submission are substantially equivalent to those manufactured by Fresenius USA.
VII. Product Description: The Medisystems' Peritoneal Dialysis Sets comprise a number of codes to facilitate peritoneal dialysis procedures. The Medisystems' Peritoneal Dialysis Sets consist of tubing and componentry to allow connection between a container of dialysate solution and the patient's indwelling catheter for instillation into and retention of the dialysate in the peritoneal cavity. The Peritoneal Dialysis Sets then allow exchange of fresh dialysate by providing a means to aseptically drain the used dialysate from the peritoneal cavity into a collection bag for disposal.
VIII. Statement of Intended Use Compared to Predicate Device: The intended use of the Medisystems' Peritoneal Dialysis Sets is identical to that of the predicate device; to provide a means to exchange dialysate solution in peritoneal dialysis procedures for the treatment of patients with kidney failure.
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K963668
IX. Discussion of Technological Characteristics: The technical characteristics of the device may be divided into three elements:
-
- Components that allow access to bags of dialysis solution and to the patient's indwelling catheter.
-
- Tubing components which allow the dialysis solution to be instilled into or drained from the peritoneal cavity.
-
- A drain bag that allows aseptic collection of the used dialysis solution drained from the patient.
These technological characteristics are identical to those of the predicate device.
Multiple codes of the product are offered to accommodate different physicians' prescriptions and patient needs. These codes include various means of connection to a dialysis solution container, connection to the patient's in-dwelling catheter, and alternate materials of construction.
X. Safety and Effectiveness: To assure that the device is safe and effective, all finished products are tested and must meet all required release specifications before distribution. The testing required for release includes, but is not limited to; sterility, pyrogenicity, physical testing, and visual examination of both in-process and finished product.
The required testing is defined by written and approved procedures that conform to the product design specifications. This testing for the Medisystems Peritoneal Dialysis Sets is defined in detail in the "Device Master Records."
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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 stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 15 1997
Medisystems Corporation c/o Ms. Suzan Onel . ...... McKenna & Cuneo, L.L.P. 1900 K Street, N.W. Washington, D.C. 20006-1108 Re: K963668 Medisystems Peritoneal Dialysis Sets Dated: May 19, 1997 Received: May 19, 1997 Regulatory class: II 21 CFR §876.5630/Product code: 78 KDJ
Dear Ms. Onel:
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 interstated 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). You may, therefore, 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 misbranion.
If your device is classified (see above) into either class III (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 (OS) 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/odrh/dsmamam.html".
Sincerely yours,
h. W. Liao Yu
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
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510(k) Number (if known):
Device Name: Peritoneal Dialysis Sets
Indications For Use:
Medisystems Peritoneal Dialysis Set product line is indicated for use in compatible peritoneal dialysis procedures. Specific codes are indicated respectively for Continuous Ambulatory Peritoneal Dialysis (CAPD) and Cycler 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
✓
OR
Over-The-Counter Use __
Robert R. Stth
(Optional Format 1-2-96)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number_19 6 3668
§ 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.