(90 days)
The HomeChoice® Personal Cycler Peritoneal Dialysis System is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
The HomeChoice® Personal Cycler Peritoneal Dialysis System provides automatic control of dialysate solution exchanges for low fill volume and standard fill volume therapies with software drain logic designed specific to each fill volume range.
This document is a 510(k) summary for the Baxter HomeChoice® Personal Cycler Peritoneal Dialysis System, detailing its substantial equivalence to a previously cleared device. It is not a study report containing detailed performance data. Therefore, the information requested about acceptance criteria and study details cannot be fully extracted from the provided text.
Specifically, the document states:
"The HomeChoice® Personal Cycler Peritoneal Dialysis System is exactly the same as the predicate device, with the exception that the modified device provides low fill volume mode drain logic for renal failure patients requiring fill volumes of 60 - 1000 mLs."
This statement implies that the device's performance is expected to be substantially equivalent to the predicate device, with the only change being a software modification for handling low fill volumes. A 510(k) submission generally focuses on demonstrating substantial equivalence rather than conducting a new, exhaustive performance study with distinct acceptance criteria and outcomes for every aspect of the device.
Based on the provided text, here is what can be inferred and what is explicitly not available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated. For a 510(k) of this nature, the "acceptance criteria" likely revolve around demonstrating that the new drain logic for low fill volumes performs as intended and does not introduce new safety or effectiveness concerns, maintaining substantial equivalence to the predicate. This would typically involve software verification and validation activities (e.g., testing against specifications for drain accuracy, alarm functionality, patient safety parameters for the new fill volume range, etc.). However, these specific criteria are not detailed in this summary.
- Reported Device Performance: Not explicitly stated in quantitative terms. The document only mentions the purpose of the modification (low fill volume mode drain logic for 60-1000 mLs) and implies that it works as intended to maintain substantial equivalence. Detailed performance metrics (e.g., drain efficiency, accuracy for specific volumes, alarm response times) are not provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. Given it's a software modification to an existing device, it's possible testing was done internally by the manufacturer, but no details are provided.
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)
- This information is not applicable and not provided. The device (automated peritoneal dialysis system) does not involve interpreting medical images or data that would typically require expert consensus for establishing ground truth in the way a diagnostic AI device would. The "ground truth" here would relate to the correct functioning of the machine's software and hardware according to its specifications for liquid exchange, which is assessed through engineering and clinical performance testing, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable and not provided. See explanation for point 3.
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 is not a diagnostic AI device that assists human readers/interpreters. It is a medical device for automated peritoneal dialysis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the typical sense of "standalone AI performance." The device is largely automated, and the "drain logic" is an algorithm. Its performance would be assessed in a standalone manner (i.e., the machine performs its function without human intervention during the dialysis exchanges) to ensure it meets specifications, but this isn't framed as a "standalone AI study" in the context of diagnostic AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for a device like this would be established by engineering specifications for fluid volumes, flow rates, alarm conditions, and clinical safety and effectiveness parameters for peritoneal dialysis. This would typically be assessed through device testing, bench testing, and potentially some limited clinical validation to ensure the new drain logic performs safely and effectively for the stated patient population and fill volume range. It would not typically involve expert consensus on interpretations of medical data or pathology. Specific details are not provided.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML model that undergoes "training" on a dataset in the way a diagnostic algorithm would. The "logic" is programmed software, not a learned model from a training set.
9. How the ground truth for the training set was established
- Not applicable. See explanation for point 8.
{0}------------------------------------------------
Page 1/1
KOI 2988
DEC 0 5 2001
Renal Division
Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, II 60085-6730
847-473-6030
BAXTER
510(k) SUMMARY
HomeChoice® Personal Cycler Peritoneal Dialysis System
| Submitter's name, addresss, phone, fax, contact person | Baxter Healthcare CorporationRenal Division1620 Waukegan RoadMcGaw Park, IL 60085Phone: (847) 473-6079Fax: (847) 473-6952Contact: David Curtin |
|---|---|
| Date prepared | September 4, 2001 |
| Trade name of device | HomeChoice® Personal Cycler Peritoneal DialysisSystem |
| Common name | Automated Peritoneal Dialysis System |
| Classification name | Peritoneal dialysis system and Accessories(per 21CFR 876.5630) |
| Substantially equivalent devices | HomeChoice® Personal Cycler Peritoneal DialysisSystem[510(k) number K923065] |
| Description of the device | The HomeChoice® Personal Cycler Peritoneal DialysisSystem provides automatic control of dialysate solutionexchanges for low fill volume and standard fill volumetherapies with software drain logic designed specific toeach fill volume range. |
| Intended use of the device | The HomeChoice® Personal Cycler Peritoneal DialysisSystem is intended for automatic control of dialysatesolution exchanges in the treatment of pediatric and adultrenal failure patients undergoing peritoneal dialysis. |
| Comparison of technologicalcharacteristics between new andpredicate devices | The HomeChoice® Personal Cycler Peritoneal DialysisSystem is exactly the same as the predicate device, withthe exception that the modified device provides low fillvolume mode drain logic for renal failure patientsrequiring fill volumes of 60 - 1000 mLs. |
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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" arranged around the perimeter. Inside the circle is a stylized design resembling an eagle or bird in flight, composed of three curved lines.
DEC 5 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
David E. Curtin, R.A.C. Associate Director, Regulatory Affairs Baxter Healthcare Corporation Renal Division, MPR-A2E 1620 Waukegan Road MCGAW PARK IL 60085
Re: K012988 Trade/Device Name: HomeChoice® Personal Cycler Peritoneal Dialysis System (Models 5C8310, 5C8302, 5C4471 and 5C4469) Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: 78 FKX Dated: September 6, 2001 Received: September 6, 2001
Dear Mr. Curtin:
We have reviewed your Section 510(k) premarket notification of intent to market the devices in diest We have reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) the actessed predicate devices marketed in interstate for use stated in the encrosule, to regally manatiment date of the Medical Device Amendments, or to commerce prior to May 28, 1970, the enaomience with the provisions of the Federal Food, Drug, devices that have been reclassince in access approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval a and Cosment Act (Act) that to not require subject to the general controls provisions of the Act. The You may, mercede, market the device, becycer or use in the most registration, listing of general controls provisions of the rise, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), and If your device is classified (Scc above) into exting major regulations affecting your device can be
it may be subject to additional controls. Existing major readition EDA m It may oe subject to additional condois. Extreming Lington of 898. In addition, FDA may found in the Code of I ederal Regulations) your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination are not mean Please be advised that FDA s issualled of a backed complies with other requirements of the Act
that FDA has made a determination that your device complies with other requirem that FDA has made a decemmanon that Jour as Jour as a ministered by other Federal and listing and listing and listing and listing and listing and listing and listing and list or any Federal Statutes and regulations and limited to: registration and listing comply whil all the Act 3 requirements, medaling on analufacturing practice requirements as set (21 CFR Patt 807), labornig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QS) regarations 531-542 of the Act); 21 CFR 1000-1050.
{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 Cbrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
510(K) Number (if known):
Device Name: HomeChoice Personal Cycler Peritoneal Dialysis System
Indications for Use:
HomeChoice® Personal Cycler Peritoneal Dialysis System
The HomeChoice® Personal Cycler Peritoneal Dialysis System is intended for automatic I he HomeCholce® Felsonal Cycler i effectives by a patients undergoing peritoneal dialysis.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
OR
Concurrence of CDRH, Office Device Evaluation (ODE)
510k) Nur
Prescription Use (Per 21 CFR 801.109 Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1/2/96)
. .
§ 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.