(90 days)
Not Found
No
The summary describes a cycler system with software logic for controlling dialysate exchanges, but there is no mention of AI, ML, or related concepts. The description focuses on automated control based on pre-defined logic, not adaptive or learning algorithms.
Yes
The device is intended for the treatment of renal failure patients, which is a therapeutic purpose.
No
This device is described as controlling dialysate solution exchanges for treatment, which indicates a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "System" and mentions "automatic control of dialysate solution exchanges," which strongly implies the presence of hardware components (like pumps, valves, sensors, etc.) in addition to software. The software is described as providing "automatic control," indicating it manages hardware functions.
Based on the provided information, the HomeChoice® Personal Cycler Peritoneal Dialysis System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis." This describes a therapeutic device used to perform a medical procedure on a patient's body, not a device used to examine specimens (like blood, urine, or tissue) outside the body to diagnose or monitor a condition.
- Device Description: The description reinforces its function in controlling dialysate exchanges, which is a process performed on the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the HomeChoice® Personal Cycler Peritoneal Dialysis System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
78 FKX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric and adult
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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 Corporation
Renal Division
1620 Waukegan Road
McGaw Park, IL 60085
Phone: (847) 473-6079
Fax: (847) 473-6952
Contact: David Curtin |
|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date prepared | September 4, 2001 |
| Trade name of device | HomeChoice® Personal Cycler Peritoneal Dialysis
System |
| Common name | Automated Peritoneal Dialysis System |
| Classification name | Peritoneal dialysis system and Accessories
(per 21CFR 876.5630) |
| Substantially equivalent devices | HomeChoice® Personal Cycler Peritoneal Dialysis
System
[510(k) number K923065] |
| Description of the device | 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. |
| Intended use of the device | 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. |
| Comparison of technological
characteristics between new and
predicate devices | 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. |
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)
. .