(649 days)
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No
The summary describes a device for disinfecting peritoneal dialysis connectors and transfer sets. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The description focuses on the physical function of disinfection.
No.
The device is intended for disinfection of connectors and transfer sets used in peritoneal dialysis, not for direct therapeutic treatment of a patient's medical condition.
No
The device description states its purpose is for "moist-heat intraluminal disinfection," which is a treatment or maintenance function, not a diagnostic one.
No
The intended use describes a device used for "moist-heat intraluminal disinfection" of physical connectors (Patient Transfer Set and UltraBag™ connector or High Temperature Cap). This process inherently involves hardware components for heating and delivering moisture, not just software. The lack of a device description further supports that this summary is for a physical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a process of moist-heat disinfection of a connector used in peritoneal dialysis. This is a physical process applied to a medical device component, not a test performed on a biological sample to diagnose a condition or provide information about a physiological state.
- Lack of Biological Sample Analysis: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The description of the PDM3 and the PTS102 does not involve the analysis of any biological samples.
- Focus on Device Disinfection: The primary function described is the disinfection of a connector, which is a maintenance or preparation step for a medical device used in treatment.
Therefore, the PDM3 and the associated PTS102 transfer set, as described, fall under the category of medical devices used in treatment, not in vitro diagnostics.
N/A
Intended Use / 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 Baxte 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:
-
- a Baxter UltraBag™ dialysate solution bag connector during a Peritoneal Dialysis Solution Exchange process, or
-
- a MMS High Temperature Cap (Model 190259) when the bag connector is removed.
Product codes
78 KDJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Peritoneal Dialysis patients
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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). 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 Requlations, 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), piease contact the Office of Compliance at (301) 594-4613. 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 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/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
1
510(k) Number (if known)*: _
Device Name:
- 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 Baxte 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:
-
- a Baxter UltraBag™ dialysate solution bag connector during a Peritoneal Dialysis Solution Exchange process, or
-
- 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
triml G. Sezear
(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Devi 510(k) Number
(Optional Format 1/2/