(28 days)
Not Found
No
The summary describes a mechanical device for peritoneal dialysis and does not mention any AI or ML components or functionalities.
Yes
The device is used to transfer peritoneal dialysis solution to and from the patient, which is a therapeutic intervention for end-stage renal disease.
No
The device is used to transfer peritoneal dialysis solution to and from a patient for therapeutic purposes, not to diagnose a condition.
No
The device description clearly states it is a physical device ("single use, sterile, non-pyrogenic devices") and describes physical components and testing related to materials and connections.
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 a patient's peritoneal cavity. This is a therapeutic procedure performed on the patient, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The device is a transfer set connected to an implanted catheter, facilitating the exchange of fluids within the body. This aligns with a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, or tissue), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, this device falls under the category of a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This set is used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient 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 Sets 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 allows 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 devices 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 closed position) ●
- 8 psi Pressure Test Post Cycling (clamp in open position ●
- 5 lb Pull of Tubing to Barb Connections ●
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, "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 .
- Hemolysis .
- Physical or Chemical Information (Extractables & Leachables) .
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 25, 2019
Baxter Healthcare Kimberly Garcia Associate, Regulatory Affairs 32650 N. Wilson Road Round Lake, IL 60073
Re: K192705
Trade/Device Name: MiniCap Extended Life PD Transfer Sets Regulation Number: 21 CFR 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: KDJ Dated: September 25, 2019 Received: September 27, 2019
Dear Kimberly Garcia:
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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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,
for
Carolyn Y. Neuland, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity 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
2
Indications for Use
510(k) Number (if known)
Device Name
MiniCap Extended Life PD Transfer Sets
Indications for Use (Describe)
This set is used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient from the source solution container.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the text 'K192705' and 'Page 1 of 5' at the top. Below that is the word 'Baxter' in a large, bold, blue font. The text and logo appear to be part of a document or report.
Section 5. 510(k) Summary
September 25, 2019
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Kimberly Garcia Associate, Global Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: 224-270-4401 Fax: 224-270-4119
IDENTIFICATION OF THE DEVICE:
Common Name: Transfer Sets Trade Name or Proprietary Name: MiniCap Extended Life PD Transfer Sets Classification Panel: 78 Gastroenterology/Urology Classification: Set, Administration, For Peritoneal Dialysis, Disposable Regulation Number: 21 CFR 876.5630 Regulation Name: Set, Administration, For Peritoneal Dialysis Regulatory Class: Class II Product Code: KDJ
| Baxter Code Number | Name |
|---|---|
| 5C4482 | MiniCap Extended Life PD Transfer Set with Twist |
| Clamp | |
| 5C4483b | MiniCap Extended Life PD Transfer Set with Twist |
| Clamp - Extra Short |
Table 1. Baxter Product Code(s) for Transfer Sets
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Image /page/4/Picture/1 description: The image shows the word "Baxter" in a bold, blue font. The word is slightly slanted to the right. The font is sans-serif and appears to be a custom typeface.
PREDICATE DEVICE:
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| Extended Life CAPD | |||
| Transfer Set, Peritoneal | |||
| Dialysis Titanium | |||
| Catheter Adapter and | |||
| Locking Cap for | |||
| Titanium Catheter | |||
| Adaptera | Baxter Healthcare | ||
| Corporation | K152675 | 10/29/2015 |
Table 2. Predicate Device(s)
a 510(k) K152675 was a bundled submission for both the Extended Life CAPD Transfer Set as well as the Peritoneal Dialysis Titanium Catheter Adapter and Locking Cap for Titanium Catheter Adapter. This 510(k) will only utilize the Extended Life CAPD Transfer Set as a predicate device
b Product Code 5C4483 is included within this submission; however, no updates are being made to this device since it was cleared in K152675.
DESCRIPTION OF THE DEVICE:
The MiniCap Extended Life PD Transfer Sets 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 allows for the exchange of peritoneal dialysis solution into and out of the peritoneal cavity as prescribed.
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.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The proposed device has 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 | Current Transfer Sets | Proposed
Transfer Sets | Discussion of
Differences |
|--------------|--------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------|
| Intended use | This set is used during
Peritoneal dialysis therapy
to transfer peritoneal
dialysis solution to the | Same | N/A |
Table 3. Device Comparison
5
| ATT
1
0
5
100
| C |
|---|
| Features | Current Transfer Sets | Proposed
Transfer Sets | Discussion of
Differences |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | patient catheter from the
source solution container. | | |
| 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 | Same | 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. | Same | N/A |
| Sterile | Yes (EO) | Same | N/A |
| Non-Pyrogenic | Yes | Same | N/A |
| Single Use | Yes | Same | N/A |
| Fluid Path Materials | | | |
| Tubing 5C4482 | 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. |
| Tubing 5C4483 | Silicone (Dichlorobenzoyl
Peroxide Cured) | Same | N/A |
| Female Connector
5C4482/5C4483 | Polyester | Same | N/A |
| Catheter Adapter
5C4482/5C4483 | Polyester | Same | N/A |
Table 3. Device Comparison
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 that the proposed device is appropriately designed for its intended use.
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Image /page/6/Picture/1 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly slanted to the right, giving it a dynamic appearance. The background is plain white.
Performance Data:
The following functional testing was performed to ensure proper design and function of the devices 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 closed position) ●
- 8 psi Pressure Test Post Cycling (clamp in open position ●
- 5 lb Pull of Tubing to Barb Connections ●
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, "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 .
- Hemolysis .
- Physical or Chemical Information (Extractables & Leachables) .
7
Image /page/7/Picture/1 description: The image shows the word "Baxter" in a bold, sans-serif font. The word is a dark shade of blue. The font is slightly slanted to the right, giving it a dynamic appearance.
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.