(174 days)
Not Found
No
The document describes a disposable tubing set for peritoneal dialysis and does not mention any AI or ML capabilities.
Yes
The device is described as "intended for delivery of peritoneal dialysis therapy," which is a medical treatment.
No
This device is described as a disposable tubing administration set intended for delivery of peritoneal dialysis therapy, meaning it is used for treatment, not diagnosis.
No
The device description explicitly states it is a "disposable tubing administration set," which is a physical hardware component. The intended use also describes its function in connecting the patient and solutions to a cycler, further indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "delivery of peritoneal dialysis therapy." This is a therapeutic procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description confirms it's a "disposable tubing administration set used in automated peritoneal dialysis therapies." This further reinforces its role in delivering treatment.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information for diagnosis. The device facilitates the physical process of peritoneal dialysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The HomeChoice APD Set with Lineo Connector is intended for use with the HomeChoice Automated Personal Cycler.
The HomeChoice Integrated APD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy and is compatible with the HomeChoice Automated PD System only, and is to be used with the MiniCap Extended Life PD Transfer Set, Easy-Lock Extended Life PD Transfer Set, or Easy-Lock Transfer Set.
The HomeChoice Low Recirculation Volume APD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy in pediatric and adult renal failure patients requiring fill volumes of 60 - 1000 ml, using only the HomeChoice Automated Personal Cycler with Low Fill Mode Drain Logic.
The Lineo OptiCap is for protection of the Lineo Connector (patient line) of APD Disposable Sets with Lineo Connector that are intended for delivery of peritoneal dialysis therapy.
The HomeChoice Automated PD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy and is compatible with the HomeChoice Automated PD System only, and is to be used with the MiniCap Extended Life PD Transfer Set, Easy-Lock Extended Life PD Transfer Set, or Easy-Lock Transfer Set.
Product codes (comma separated list FDA assigned to the subject device)
78 KDJ
Device Description
HomeChoice APD Set with Lineo Connector is a disposable tubing administration set used in automated peritoneal dialysis therapies. It provides for connection of the patient and the peritoneal dialysis solutions to the automated cycler.
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)
Components of the subject HomeChoice APD Set with Lineo Connector have met the biological requirements of ISO 10993-1: Biological Evaluation of Medical devices - Part: Guidance on selection of tests. Sterilization of the HomeChoice APD Set with Lineo Connector is by a method determined and validated to ensure an SAL of
§ 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 1/2
NOV 2 0 2003
510(K) SUMMARY
| Submitter's Name: | David E. Curtin, RAC |
|---|---|
| Address: | 1620 Waukegan Rd. MPGR-A2E |
| Phone: | (847) 473-6079 |
| Fax: | (847) 473-6952 |
| Contact: | David E. Curtin |
| Date Prepared: | May 30, 2003 |
| Trade Name: | HomeChoice APD Set with Lineo Connector |
| Common Name: | Sets, Administration, for Peritoneal Dialysis, Disposable |
| Classification Name: | Peritoneal Dialysis System and Accessories 21 CFR 876.5630 |
| Equivalent Predicate: | HomeChoice APD Set (Baxter Healthcare Corp., K923065), |
| HomeChoice Low Recirculation Volume APD Set (Baxter Healthcare Corp., K012988), High Dose Disconnect Cap and | |
| MiniCap with Povidone Iodine (Baxter Healthcare Corp., K972579) and Disconnect Caps with Povidone Iodine (Baxter Healthcare Corp., K895631) | |
| Device Description: | HomeChoice APD Set with Lineo Connector is a disposable |
| tubing administration set used in automated peritoneal dialysis | |
| therapies. It provides for connection of the patient and the | |
| peritoneal dialysis solutions to the automated cycler. | |
| Intended Use: | The HomeChoice APD Set with Lineo Connector is intended |
| for use with the HomeChoice Automated Personal Cycler |
:
1
.
| Summary of the
Technological
Characteristics
Compared to the | The general design and material of the HomeChoice APD Set
with Lineo Connector is to the HomeChoice APD Set
(K923065 and K012988) and High Dose Disconnect
Cap/MiniCap (K972579 and K895631) in that it incorporates
the disinfectant feature of the Disconnect Cap/MiniCap into the
patient connector of the set. The technological characteristics
of the HomeChoice APD Set with Lineo Connector do not
raise any new types of safety and effectiveness issues, when
compared to the predicate product. |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device: | HomeChoice APD Set (Baxter Healthcare Corp), HomeChoice
Low Recirculation Volume APD Set (Baxter Healthcare
Corp.), High Dose Disconnect Cap and MiniCap with
Povidone Iodine (Baxter Healthcare Corp.) and Disconnect
Caps with Povidone Iodine (Baxter Healthcare Corp) |
| Clinical Data: | N/A |
| Conclusions Drawn | Components of the subject HomeChoice APD Set with Lineo
Connector have met the biological requirements of ISO 10993-
1: Biological Evaluation of Medical devices - Part: Guidance
on selection of tests.
Sterilization of the HomeChoice APD Set with Lineo
Connector is by a method determined and validated to ensure
an SAL of ≥ 106. Functional and physical testing is performed
prior to product release |
Additional
Information Requested by FDA:
None to date
:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its body and wings. The bird is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
Public Health Service
NOV 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
David E. Curtin, RAC Associate Director, Regulatory Affairs Renal Division Baxter Healthcare Corporation 1620 Waukegan Road MCGAW PARK IL 60085
Re: K031676
Trade/Device Name: HomeChoice Automated PD Set with Lineo Connector; #5C4469Q, 5C4468Q HomeChoice Integrated APD Set with Lineo Connector; #5C4531Q HomeChoice Low Recirculation Volume APD Set with Lineo Connector; #5C8302Q and Lineo Opticap; #5C4599Q
Regulation Number: 21 CFR§ 876.5630 Regulation Name: Peritoneal Dialysis System and Accessories Regulatory Class: II Product Code: 78 KDJ Dated: August 29, 2003 Received: September 2, 2003
Dear Mr. Curtin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited 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) regulation (21 CFR Part 820); and if applicable, the electronic 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) 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 the 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" (21CFR Part 807.97) you may obtain. 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 C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
4
510(k) Number (if known): K031676
Device Name: HomeChoice Integrated APD Set with Lineo Connector
Indications For Use:
The HomeChoice Integrated APD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy and is compatible with the HomeChoice Automated PD System only, and is to be used with the MiniCap Extended Life PD Transfer Set, Easy-Lock Extended Life PD Transfer Set, or Easy-Lock Transfer Set.
(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)
22
Division of Reproduct and Radiological Devices 510(k) Number
G:\510k\Lineo\response!\Indications for Use Statement
5
510(k) Number (if known):________________________________________________________________________________________________________________
Device Name: HomeChoice Low Recirculation Volume APD Set with Lineo Connector
Indications For Use:
The HomeChoice Low Recirculation Volume APD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy in pediatric and adult renal failure patients requiring fill volumes of 60 - 1000 ml, using only the HomeChoice Automated Personal Cycler with Low Fill Mode Drain Logic.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdomi nd Radiological Dev
G:\510k\Lineo\response 1\Indications for Use Statement
23
6
K031676 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Lineo OptiCap
Indications For Use:
The Lineo OptiCap is for protection of the Lineo Connector (patient line) of APD Disposable Sets with Lineo Connector that are intended for delivery of peritoneal dialysis therapy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
Nancy C Brogdon
Division Sign Off
Reproductive, Abdom and Radiological D 510(k) Number
24
7
510(k) Number (if known): K031676
Device Name: HomeChoice Automated PD Set with Lineo Connector
Indications For Use:
The HomeChoice Automated PD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy and is compatible with the HomeChoice Automated PD System only, and is to be used with the MiniCap Extended Life PD Transfer Set, Easy-Lock Extended Life PD Transfer Set, or Easy-Lock Transfer Set.
(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 Brogdon
(Division Sign-Off)
vision of Reproductive, Abdo and Radiological De 510(k) Number
G:\510k\Lineo\response 1\Indications for Use Statement