(88 days)
No
The device description and performance studies focus on the physical components, materials, and sterilization processes of a disposable tubing set for peritoneal dialysis. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as a set of tubing and bags for drainage and infusion of PD solution, not for providing therapy itself. Its function is to facilitate the exchange of fluid during peritoneal dialysis, which is a therapeutic process, but the device itself is a delivery system, not a therapeutic agent.
No
This device is designed for the drainage and infusion of peritoneal dialysis solution, which is a therapeutic function, not a diagnostic one. It facilitates the exchange of fluid in peritoneal dialysis.
No
The device description clearly outlines a physical, Y-shaped tubing set with connectors, a drain bag, and clamps, indicating it is a hardware device used for peritoneal dialysis. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "drainage and infusion of PD solution during a peritoneal dialysis exchange." This describes a therapeutic procedure involving the exchange of fluids within the body, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a system for fluid transfer (draining spent dialysate and infusing new solution). It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other human specimen. There is no mention of reagents, assays, or any other elements typically associated with IVD devices.
In summary, the device is a medical device used for performing peritoneal dialysis, which is a treatment, not a diagnostic procedure.
N/A
Intended Use / Indications for Use
The Ultra Sets are designed for drainage and infusion of PD solution during a peritoneal dialysis exchange.
Product codes
Not Found
Device Description
The Y-shaped design of the set enables patients to initially drain the dialysis solution from the peritoneum into the attached drain bag and then to fill new dialysis solution from a solution container into the patient's peritoneum. The plastic Y-shaped configuration serves as a junction for three lengths of tubing. The first length of tubing is the patient connector and connects to the patient's transfer set via a luer lock connection. The second length of tubing has a spike connector for connection to the new solution container and an occlusion clamp which is utilized during the solution exchange. The third length of tubing has a empty drain bag and an occlusion clamp for collection of spent dialysate during the dialysis exchange.
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
Not Found
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
Components of the Ultra Set CAPD Disposable Disconnect Y-set and 3L Ultra Set CAPD Disposable Disconnect Y-set have previously met the USP XXII Class VI biological requirements and guidelines for safety screening of materials. The sets are gamma sterilized at the minimum sterilizing dose (msd) by a method determined and verified using Method 1 of the American National Standard Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) Guideline for radiation sterilization. The msd is between 14.3 and 25 kilogray (1.43-2.50 Mrad). The msd is audited quarterly. The testing specification for pyrogen evaluation detail the FDA guideline for the Limulus Amebocyte Lysate (LAL) Test. The sets are tested to an endotoxin limit of 0.5 EU/mL in accordance with the established limit for medical devices and as validated under FDA's "Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices", December 1987. Functional and physical testing are performed as in process and/or final inspections prior to release of product release ensuring a quality product.
Key Metrics
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
长961825
510(k) SUMMARY
| Submitter's name and
Address: | David C. Ross, Pharm.D., RAC
Baxter Healthcare Corporation, Renal Division
1620 Waukegan Road
McGaw Park, IL 60085 |
|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number:
Fax Number: | (847) 473-6081
(847) 473-6952 |
| Contact: | David Ross |
| Trade Name: | Ultra Set CAPD Disposable Disconnect Y-Set and 3L Ultra
Set CAPD Disposable Disconnect Y-Set |
| Common Name: | Disconnect Y-Sets with solution drainage bag for Peritoneal
Dialysis (PD) |
| Classification Name: | Peritoneal dialysis system and accessories per 21 CFR
876.5630 |
| Equivalent Predicate: | Baxter CAPD Disposable Disconnect Y-Set (K902526) and
UV-III Disposable Disconnect Y-Set (K883239). |
| Device Description: | The Y-shaped design of the set enables patients to initially
drain the dialysis solution from the peritoneum into the
attached drain bag and then to fill new dialysis solution from
a solution container into the patient's peritoneum. The
plastic Y-shaped configuration serves as a junction for three
lengths of tubing. The first length of tubing is the patient
connector and connects to the patient's transfer set via a luer
lock connection. The second length of tubing has a spike
connector for connection to the new solution container and an
occlusion clamp which is utilized during the solution
exchange. The third length of tubing has a empty drain bag
and an occlusion clamp for collection of spent dialysate
during the dialysis exchange. |
| Intended Use: | The Ultra Sets are designed for drainage and infusion of PD
solution during a peritoneal dialysis exchange. |
| Summary of the
technological
characteristics compared
to the predicate device: | In general, the design and materials of the subject disposable
disconnect Y-sets are the same as the Baxter predicate
devices. Differences in the subject Y-sets compared to the
Baxter predicate devices consist of minor differences in the
solution container and patient connections. Additionally, the
drain bag on the 3L Ultra Set is five liters to accommodate
larger effluent volumes. |
| Clinical Data: | Not applicable |
| Conclusions drawn from
tests: | Components of the Ultra Set CAPD Disposable Disconnect
Y-set and 3L Ultra Set CAPD Disposable Disconnect Y-set
have previously met the USP XXII Class VI biological
requirements and guidelines for safety screening of materials.
The sets are gamma sterilized at the minimum sterilizing dose
(msd) by a method determined and verified using Method 1
of the American National Standard Institute
(ANSI)/Association for the Advancement of Medical
Instrumentation (AAMI) Guideline for radiation sterilization.
The msd is between 14.3 and 25 kilogray (1.43-2.50 Mrad).
The msd is audited quarterly. |
| | The testing specification for pyrogen evaluation detail the
FDA guideline for the Limulus Amebocyte Lysate (LAL)
Test. The sets are tested to an endotoxin limit of 0.5 EU/mL
in accordance with the established limit for medical devices
and as validated under FDA's "Guideline on Validation of the
Limulus Amebocyte Lysate Test as an End-Product
Endotoxin Test for Human and Animal Parenteral Drugs,
Biological Products, and Medical Devices", December 1987.
Functional and physical testing are performed as in process
and/or final inspections prior to release of product release
ensuring a quality product. |
| Additional information
requested by FDA: | None to date. |
୧୧
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1
David C. Ross
David C. Ross, Pharm.D., RAC
Manager, Regulatory Affairs
5/8/96
Date