(263 days)
Not Found
No
The summary describes a mechanical device for peritoneal dialysis and explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes
The device is used to facilitate the transfer of peritoneal dialysis solution during Peritoneal Dialysis therapy, which is a medical treatment for kidney failure. Therefore, it is a therapeutic device.
No
The device is described as a transfer set used to move peritoneal dialysis solution to and from a patient's catheter. Its function is to facilitate the exchange of fluid for treatment, not to diagnose a condition or disease.
No
The device description clearly indicates it is a physical, single-use, sterile, non-pyrogenic device made of materials like silicone, designed to connect to an implanted catheter for peritoneal dialysis. The performance studies focus on physical properties and functionality of the hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to transfer peritoneal dialysis solution to and from the patient's peritoneal cavity. This is a therapeutic procedure, not a diagnostic one.
- Device Description: The description details a device used for the physical exchange of fluids within the body for treatment purposes. It does not mention any analysis of samples taken from the body or any diagnostic function.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting substances, or providing information for diagnosis.
- Performance Studies: The performance studies focus on the physical integrity and functionality of the device for fluid transfer, not on diagnostic accuracy or performance.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is purely for the physical delivery and removal of dialysis solution.
N/A
Intended Use / Indications for Use
These sets are used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient catheter from the source solution container.
Product codes (comma separated list FDA assigned to the subject device)
KDJ
Device Description
The MiniCap Extended Life PD Transfer Set with Twist Clamp – Code 5C4482A and MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 are single use, sterile, non-pyrogenic devices for use with Baxter peritoneal dialysis systems. A Transfer Set is connected to a Titanium Adapter that is at the end of an implanted peritoneal catheter. The Transfer Sets stay connected to the patient and allow for the exchange of peritoneal dialysis solution into and out of the peritoneal cavity as prescribed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal cavity
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following functional testing was performed to ensure proper design and function of the devise based on the change to the material from Dichlorobenzoyl peroxide cured silicone to platinum cured silicone:
- Visual Inspection
- Initial Pressure Test (clamp in closed position)
- Cycling (conditioning step prior to pressure tests)
- 8 psi Pressure Test Post Cycling (clamp in both open and closed position)
- 5 lb Pull of Tubing to Barb Connection
- Functionality after Iodine Exposure (over 48 hours continuous and 6 months simulated use)
- Flow Rate (after iodine exposure)
- Shelf Life
Biocompatibility assessment has been conducted on all materials to the category of external communicating devices with tissue bone dentin and indirect blood path contact for long-term contact duration. The biocompatibility evaluation for these devices was conducted in accordance with ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing", as recognized by the FDA, and FDA Guidance Document, "Use of International Standard ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process'', issued June 16, 2016. The battery of testing included:
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- Sub-chronic Toxicity
- Genotoxicity
- Implantation
- Hemolysis
In addition, extractables and leachables was performed and a toxicological evaluation completed for the change to platinum cured silicone. The extractables and leachables testing was performed per ISO 9003-18:2020, "Biological evaluation of medical devices - Part 18: Chemical characterization of materials". The toxicological evaluation was performed per ISO 10993-17:2002, "Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances".
- Physical or Chemical Information (extractables & leachables)
- . Toxicological Evaluation
The non-clinical data supports the safety of the proposed devices and demonstrates that the proposed devices perform comparably to the predicate device that is currently marketed for the same intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 12, 2024
Baxter Healthcare Brad Roynon Associate Director, Regulatory Affairs 2512 W. Illinois Route 120 Round Lake, Illinois 60073
Re: K231849
Trade/Device Name: MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 Regulation Number: 21 CFR 876.5630 Regulation Name: Set, Administration, For Peritoneal Dialysis Regulatory Class: Class II Product Code: KDJ Dated: February 15, 2024 Received: February 15, 2024
Dear Brad Roynon:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Maura Rooney -S
Maura Rooney Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity
2
and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K231849
Device Name
MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483
Indications for Use (Describe)
These sets are used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient catheter from the source solution container.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5. 510(k) Summary
JUNE 23, 2023
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Brad Roynon Assoc. Director, Global Regulatory Affairs Kidney Care PD 25212 W. Illinois Route 120 Round Lake, IL 60073 Telephone: +1.262.581.7157 Fax: +1.224.270.4119
IDENTIFICATION OF THE DEVICE:
Common Name: Transfer Sets Trade/Device Name: MiniCap Extended Life PD Transfer Set with Twist Clamp – Code 5C4482A MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 Classification Panel: 78 Gastroenterology/Urology Regulation Number: 21 CFR 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: Class II Product Code: KDJ
Table 1. Baxter Product Code(s) for Transfer Sets
| Baxter Code Number | Name |
|---|---|
| 5C4482A | MiniCap Extended Life PD Transfer Set with Twist |
| Clamp | |
| 5C4483 | MiniCap Extended Life PD Transfer Set with Twist |
| Clamp - Extra Short |
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PREDICATE DEVICE:
| Table 2. Predicate Device(s) | |||
|---|---|---|---|
| -- | -- | -- | ------------------------------ |
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| MiniCap Extended Life | |||
| PD Transfer Sets | Baxter Healthcare | ||
| Corporation | K152675 | 10/29/2015 |
DESCRIPTION OF THE DEVICE:
The MiniCap Extended Life PD Transfer Set with Twist Clamp – Code 5C4482A and MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 are single use, sterile, non-pyrogenic devices for use with Baxter peritoneal dialysis systems. A Transfer Set is connected to a Titanium Adapter that is at the end of an implanted peritoneal catheter. The Transfer Sets stay connected to the patient and allow for the exchange of peritoneal dialysis solution into and out of the peritoneal cavity as prescribed.
INDICATIONS FOR USE:
These sets are used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient catheter from the source solution container.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The proposed devices have equivalent technological characteristics as Baxter's currently legally marketed Transfer Sets cleared under 510(k) premarket notification K152675 (cleared on October 29, 2015). The intended use, design and function of the proposed devices are equivalent to the predicate device.
| Features | Predicate Device
Cleared under
K152675 | Proposed Device
Transfer Sets | Discussion of
Differences |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | This set is used
during Peritoneal
dialysis therapy to
transfer peritoneal
dialysis solution to
the patient catheter
from the source
solution container. | These sets are used during
Peritoneal Dialysis therapy to
transfer peritoneal dialysis
solution to the patient catheter
from the source solution
container. | N/A |
| Features | Predicate Device
Cleared under
K152675 | Proposed Device
Transfer Sets | Discussion of
Differences |
| Indications for
Use | This set is used
during Peritoneal
dialysis therapy to
transfer peritoneal
dialysis solution to
the patient catheter
from the source
solution container. | These sets are used during
Peritoneal Dialysis therapy to
transfer peritoneal dialysis
solution to the patient catheter
from the source solution
container. | N/A |
| Contraindications | Do not use povidone-
iodine to connect the
Transfer Set to the
Baxter Titanium
Adapter if there is a
known history of
allergic reaction to
iodine. Use other
disinfectants or
antiseptic agents that
do not contain iodine,
hydrogen peroxide,
alcohol or bleach. | Do not use povidone-iodine to
connect the Transfer Set to the
Baxter Titanium Adapter if there
is a known history of allergic
reaction to iodine. Use other
disinfectants or antiseptic agents
that do not contain iodine,
hydrogen peroxide, alcohol or
bleach or chlorhexidine gluconate. | Under a previous
change,
chlorhexidine
gluconate was
added to the
Contraindications
section. |
| Sterile | Yes (EO) | Same | N/A |
| Non-Pyrogenic | Yes | Same | N/A |
| Single Use | Yes | Same | N/A |
| Fluid Path Materials | | | |
| Tubing
5C4482A/5C4483 | Silicone
(Dichlorobenzoyl
Peroxide Cured) | Silicone (Platinum Cured) | The proposed
tubing material
has passed
functional testing
for its intended
use. Design
control activities
have confirmed
that there is no
impact to safety
or effectiveness. |
| Female Connector
5C4482A/5C4483 | Polyester | Same | N/A |
| Catheter Adapter
5C4482A/5C4483 | Polyester | Same | N/A |
Table 3. Device Comparison
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Table 3. Device Comparison
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DISCUSSION OF NONCLINICAL TESTS:
Baxter Healthcare Corporation conducts risk analysis to determine the design verification tests that need to be conducted based on the change being proposed. All results meet their acceptance criteria and support the idea that the proposed device is appropriately designed for its intended use.
Performance Data:
The following functional testing was performed to ensure proper design and function of the devise based on the change to the material from Dichlorobenzoyl peroxide cured silicone to platinum cured silicone:
- Visual Inspection
- Initial Pressure Test (clamp in closed position)
- Cycling (conditioning step prior to pressure tests)
- 8 psi Pressure Test Post Cycling (clamp in both open and closed position)
- 5 lb Pull of Tubing to Barb Connection
- Functionality after Iodine Exposure (over 48 hours continuous and 6 months simulated use)
- Flow Rate (after iodine exposure)
- Shelf Life
Biocompatibility:
Biocompatibility assessment has been conducted on all materials to the category of external communicating devices with tissue bone dentin and indirect blood path contact for long-term contact duration. The biocompatibility evaluation for these devices was conducted in accordance with ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing", as recognized by the FDA, and FDA Guidance Document, "Use of International Standard ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process'', issued June 16, 2016. The battery of testing included:
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity
- Acute Systemic Toxicity
8
K231849 Page 5 of 5
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- Material Mediated Pyrogenicity ●
- Sub-chronic Toxicity
- Genotoxicity
- Implantation ●
- Hemolysis
In addition, extractables and leachables was performed and a toxicological evaluation completed for the change to platinum cured silicone. The extractables and leachables testing was performed per ISO 9003-18:2020, "Biological evaluation of medical devices - Part 18: Chemical characterization of materials". The toxicological evaluation was performed per ISO 10993-17:2002, "Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances".
- Physical or Chemical Information (extractables & leachables)
- . Toxicological Evaluation
CONCLUSION:
The non-clinical data supports the safety of the proposed devices and demonstrates that the proposed devices perform comparably to the predicate device that is currently marketed for the same intended use.