PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE

K974387 · Microwave Medical Systems, Inc. · KDJ · Sep 1, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K974387
• Device Name: PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE
• Applicant: Microwave Medical Systems, Inc.
• Product Code: KDJ · Gastroenterology, Urology
• Decision Date: Sep 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PDM3 is intended for use by Peritoneal Dialysis patients in moist-heat intraluminal disinfection of ONLY the MMS PTS102 Patient Transfer Set connector when mated with a Baxter UltraBag™ connector or with a MMS 190259 High Temperature Cap. The MMS PTS102 Transfer Set is intended for use by Peritoneal Dialysis Patients to connect between the patient’s catheter and either: 1) a Baxter UltraBag™ dialysate solution bag connector during a Peritoneal Dialysis Solution Exchange process, or 2) a MMS High Temperature Cap (Model 190259) when the bag connector is removed.

Device Story

PDM3 is a peritoneal dialysis accessory designed for moist-heat intraluminal disinfection of the MMS PTS102 patient transfer set connector. Device operates by applying heat to the connector interface when mated with a Baxter UltraBag connector or MMS 190259 high-temperature cap. Used by patients in home settings to maintain sterility of the transfer set during dialysis solution exchanges. By disinfecting the intraluminal space, the device aims to reduce the risk of peritonitis associated with peritoneal dialysis. The system provides a controlled thermal environment to ensure effective disinfection without damaging the connector components.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Moist-heat disinfection system; designed for use with MMS PTS102 transfer set, Baxter UltraBag connectors, and MMS 190259 high-temperature caps. Operates via controlled thermal application for intraluminal disinfection.

Indications for Use

Indicated for peritoneal dialysis patients requiring intraluminal disinfection of the MMS PTS102 patient transfer set connector when used with compatible Baxter UltraBag connectors or MMS 190259 high-temperature caps.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• K913110

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

SEP - 1 1999

Mr. Kenneth L. Carr
President and Chief Executive Officer
Microwave Medical Systems, Inc.
310-312 School Street
Acton, MA 01720-5414

Re: K974387
PDM3, Peritoneal Dialysis Device and Accessories
Dated: June 2, 1999
Received: June 3, 1999
Regulatory Class: II
21 CFR §876.5630/Procode: 78 KDJ

Dear Mr. Carr:

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 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). 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 (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 requirements, 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 the Electronic Product 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,


CAPT Daniel G. Schultz, M.D.
Acting 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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510(k) Number (if known)*: K974387

Device Name: PDM3, Peritoneal Dialysis Device and Accessories

* New 510(k) Supplement Notification to: K913110

## Indications for Use:

The PDM3 is intended for use by Peritoneal Dialysis patients in moist-heat intraluminal disinfection of ONLY the MMS PTS102 Patient Transfer Set connector when mated with a Baxter UltraBag™ connector or with a MMS 190259 High Temperature Cap.

The MMS PTS102 Transfer Set is intended for use by Peritoneal Dialysis Patients to connect between the patient’s catheter and either:

1) a Baxter UltraBag™ dialysate solution bag connector during a Peritoneal Dialysis Solution Exchange process, or
2) a MMS High Temperature Cap (Model 190259) when the bag connector is removed.

(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

(Optional Format 1/2)

David G. Seger
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K974387/S²⁰²