(62 days)
No
The document describes a device for automated control of dialysis fluid exchanges based on clinician prescriptions, with no mention of AI or ML terms, image processing, or data-driven learning processes.
Yes
The device is described as treating pediatric and adult renal failure patients undergoing peritoneal dialysis, which is a therapeutic intervention.
No
Explanation: The device is described as controlling dialysate solution exchanges for treatment, not for diagnosing a medical condition. It's a treatment delivery system, not a diagnostic tool.
No
The device description explicitly states "The HomeChoice Automated Personal Cycler" and refers to "Bench testing was performed on the HomeChoice Automated Personal Cycler," indicating a physical hardware component is involved in addition to the software.
Based on the provided information, the HomeChoice Automated Personal Cycler Peritoneal Dialysis System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of renal failure patients undergoing peritoneal dialysis. This involves the physical process of exchanging dialysate fluid within the patient's body.
- Device Description: The device description reinforces this by stating it "automatically cycles peritoneal dialysis fluid."
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on bodily fluids.
The device is a therapeutic device used for a medical treatment, not a diagnostic device used for analyzing samples.
N/A
Intended Use / Indications for Use
The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
The HomeChoice Automated 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
FKX
Device Description
The HomeChoice Automated Personal Cycler, version 8.9 software is used for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis therapy. The HomeChoice Automated Personal Cycler automatically cycles peritoneal dialysis fluid in the amounts and time prescribed by a clinician.
The general design and material of the HomeChoice Automated Personal Cycler is identical to the HomeChoice Automated Personal Cycler cleared under K923065 & K012988. It does not raise any new types of safety and effectiveness issues when compared to the predicate product.
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
Bench testing was performed on the HomeChoice Automated Personal Cycler to support substantial equivalence to the predicate device, as well as demonstrating that the device operates as intended and is safe and efficacious. Functional testing for delivery integrity and conformance to manufacturing specifications are performed as in-process and/or final inspections prior to product release to ensure a quality product.
Key Metrics
Not Found
Predicate Device(s)
HomeChoice Automated Personal Cycler Peritoneal Dialysis System (K923065 and K012988)
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
Image /page/0/Picture/1 description: The image shows the text "K053512" at the top. Below that, the text "Page 1 of 2" is written in handwriting. To the right of that, the text "Page 1 of 2 Section 5" is written in a printed font. The image appears to be a page from a document.
FEB 1 6 2006
510(K) SUMMARY
| Submitter's Name: | Michael C. Garcia |
|---|---|
| Address: | 1620 Waukegan Rd. MPGR-AL |
| Phone: | (847) 473-6896 |
| Fax: | (847) 785-5116 |
| Contact: | David E. Curtin |
| (847) 473-6079 | |
| Date Prepared: | 12/09/05 |
| Trade Name: | HomeChoice Automated Personal Cycler |
| Common Name: | APD Cycler |
| Classification Name: | Peritoneal dialysis system and accessories per 21 CFR |
| 876.5630 | |
| Equivalent Predicate: | HomeChoice Automated Personal Cycler Peritoneal |
| Dialysis System (K923065 and K012988) | |
| Device Description: | The HomeChoice Automated Personal Cycler, version 8.9 |
| software is used for automatic control of dialysate solution | |
| exchanges in the treatment of pediatric and adult renal | |
| failure patients undergoing peritoneal dialysis therapy. The | |
| HomeChoice Automated Personal Cycler automatically | |
| cycles peritoneal dialysis fluid in the amounts and time | |
| prescribed by a clinician. |
1
Image /page/1/Picture/1 description: The image contains handwritten text on a white background. The text at the top reads 'K053512'. Below that, the text reads 'Page 2 of 2'.
| Intended Use: | The HomeChoice Automated Personal Cycler is intended
for automatic control of dialysate solution exchanges in the
treatment of pediatric and adult renal failure patients
undergoing peritoneal dialysis. |
|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of the
Technological
Characteristics
Compared to the
Predicate Device: | The general design and material of the HomeChoice
Automated Personal Cycler is identical
to the HomeChoice Automated Personal Cycler cleared
under K923065 & K012988. It does not raise any new
types of safety and effectiveness issues when compared
to the predicate product |
| Clinical Data: | N/A |
| Conclusions Drawn | Validation and Verification testing was successful in
demonstrating that all design requirements have been met.
Bench testing was performed on the HomeChoice
Automated Personal Cycler to support substantial
equivalence to the predicate device, as well as
demonstrating that the device operates as intended and is
safe and efficacious.
Functional testing for delivery integrity and conformance to
manufacturing specifications are performed as in-process
and/or final inspections prior to product release to ensure a
quality product. |
| Additional
Information
Requested by FDA: | None to date |
2
Image /page/2/Picture/1 description: The image shows a circular logo with a stylized eagle in the center. The eagle's wings are depicted with three curved lines, and its head is facing left. The words "DEPARTMENT OF" are arranged vertically along the left side of the circle, and "HUMAN SERVICES USA" are arranged vertically along the right side of the circle. The text is in a small, sans-serif font and is oriented to follow the curve of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 6 2006
David E. Curtin, RAC Associate Director, Global Regulatory Affairs Baxter Healthcare Corporation Renal Division, MPGR-A2E 1620 Waukegan Road MCGAW PARK IL 60085
Re: K053512
K 053312
Trade/Device Name: HomeChoice Automated Personal Cycler, Models 5C4471 and 5C8310 Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: FKX Dated: December 15, 2005 Received: December 16, 2005
Dear Mr. Curtin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced We have revewed your SCC001 510(K) promation investions for the indications for use stated in above and have decemined the devices marketed in interstate commerce prior to the enclosure) to regally marketed predical Device Amendments, or to devices that have been May 28, 1970, the chacultion date of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the do not require approval of a premiance approvations of the Act. The general controls provisions of the Act device, subject to the general controls provisions 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 If your device is classince (see ao ro) into can controls. Existing major regulations affecting your Approval), it illay de subject to such address. Title 21, Parts 800 to 898. In addition, FDA device can oc tound in the Coucerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that Please be advised that I DA s 133dailed of a subscanning with other requirements of the Act or any
FDA has made a determination that your device complies with other with all F DA has made a decemination mad your device contines. You must comply with all the Federal statues and regulations administered to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (ZT CFR Part 801); good manufacturing product radiation control product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k)
10 algguner and and the first of a line of a beteratiol aquivalence of your devi This letter will allow you to begin maketing your antile of your device of your device to a legally
premarket notification. The FDA finding of substantial equir device and t premarket notification. The FDA Inding of substantial equivale of 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
r and the many of the following numbers, hased on the regulation numbers, If you desire specific advice for your device on our labeling regarities.
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misonalians of tesponsibilities under the Act from the 807.97). You may obtain other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address 056-2011-01-01-01-01-01-2019/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: HomeChoice Automated Personal Cycler
Indications For Use: HomeChoice Automated Personal Cycler
The HomeChoice Automated Personal Cycler Peritoneal Dialysis System is intended for The TromeChotee Praisition exchanges in the treatment of pediatric and adult renal failure patients undergoing 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 | ✓ |
|---|---|
| ------------------ | ------------------------------------------------- |
(Per 21 CFR 801.109)
OR Over-The-Counter Use__
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number