MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483

K231849 · Baxter Healthcare · KDJ · Mar 12, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: 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
• Applicant: Baxter Healthcare
• Product Code: KDJ · Gastroenterology, Urology
• Decision Date: Mar 12, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These sets are used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient catheter from the source solution container.

Device Story

Single-use, sterile, non-pyrogenic transfer sets for peritoneal dialysis systems; connects to titanium adapter on implanted peritoneal catheter. Facilitates fluid exchange between solution container and peritoneal cavity. Used in clinical or home settings by patients or caregivers. Device consists of platinum-cured silicone tubing and polyester connectors. Twist clamp manages fluid flow. Safety verified via functional testing (pressure, flow rate, pull strength) and biocompatibility assessment (ISO 10993-1). Benefits include reliable, sterile fluid delivery for dialysis therapy.

Clinical Evidence

No clinical data. Bench testing only. Performance verified through visual inspection, pressure testing (8 psi), pull testing (5 lb), flow rate testing after iodine exposure, and shelf-life studies. Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, sub-chronic toxicity, genotoxicity, implantation, and hemolysis. Extractables and leachables analysis performed per ISO 10993-18 with toxicological evaluation per ISO 10993-17.

Technological Characteristics

Single-use, sterile (EO), non-pyrogenic transfer set. Materials: Platinum-cured silicone tubing, polyester female connector and catheter adapter. External communicating device with long-term tissue/indirect blood path contact. Biocompatibility per ISO 10993-1. Chemical characterization per ISO 10993-18.

Indications for Use

Indicated for patients undergoing Peritoneal Dialysis therapy requiring transfer of dialysis solution from a source container to an implanted peritoneal catheter. Contraindicated for patients with a known history of allergic reaction to iodine, hydrogen peroxide, alcohol, bleach, or chlorhexidine gluconate when connecting the set to the Baxter Titanium Adapter.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MiniCap Extended Life PD Transfer Sets (K152675)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Maura Rooney -S

Maura Rooney Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity

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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

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#### 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: [phone] Fax: [phone]

# 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<br>Clamp |
| 5C4483 | MiniCap Extended Life PD Transfer Set with Twist<br>Clamp - Extra Short |

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## PREDICATE DEVICE:

| | | | Table 2. Predicate Device(s) |
|--|--|--|------------------------------|
|--|--|--|------------------------------|

| Device | Company | Predicate 510(k) | Clearance Date |
|-------------------------------------------|----------------------------------|------------------|----------------|
| MiniCap Extended Life<br>PD Transfer Sets | Baxter Healthcare<br>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<br>Cleared under<br>K152675 | Proposed Device<br>Transfer Sets | Discussion of<br>Differences |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | This set is used<br>during Peritoneal<br>dialysis therapy to<br>transfer peritoneal<br>dialysis solution to<br>the patient catheter<br>from the source<br>solution container. | These sets are used during<br>Peritoneal Dialysis therapy to<br>transfer peritoneal dialysis<br>solution to the patient catheter<br>from the source solution<br>container. | N/A |
| Features | Predicate Device<br>Cleared under<br>K152675 | Proposed Device<br>Transfer Sets | Discussion of<br>Differences |
| Indications for<br>Use | This set is used<br>during Peritoneal<br>dialysis therapy to<br>transfer peritoneal<br>dialysis solution to<br>the patient catheter<br>from the source<br>solution container. | These sets are used during<br>Peritoneal Dialysis therapy to<br>transfer peritoneal dialysis<br>solution to the patient catheter<br>from the source solution<br>container. | N/A |
| Contraindications | Do not use povidone-<br>iodine to connect the<br>Transfer Set to the<br>Baxter Titanium<br>Adapter if there is a<br>known history of<br>allergic reaction to<br>iodine. Use other<br>disinfectants or<br>antiseptic agents that<br>do not contain iodine,<br>hydrogen peroxide,<br>alcohol or bleach. | Do not use povidone-iodine to<br>connect the Transfer Set to the<br>Baxter Titanium Adapter if there<br>is a known history of allergic<br>reaction to iodine. Use other<br>disinfectants or antiseptic agents<br>that do not contain iodine,<br>hydrogen peroxide, alcohol or<br>bleach or chlorhexidine gluconate. | Under a previous<br>change,<br>chlorhexidine<br>gluconate was<br>added to the<br>Contraindications<br>section. |
| Sterile | Yes (EO) | Same | N/A |
| Non-Pyrogenic | Yes | Same | N/A |
| Single Use | Yes | Same | N/A |
| Fluid Path Materials | | | |
| Tubing<br>5C4482A/5C4483 | Silicone<br>(Dichlorobenzoyl<br>Peroxide Cured) | Silicone (Platinum Cured) | The proposed<br>tubing material<br>has passed<br>functional testing<br>for its intended<br>use. Design<br>control activities<br>have confirmed<br>that there is no<br>impact to safety<br>or effectiveness. |
| Female Connector<br>5C4482A/5C4483 | Polyester | Same | N/A |
| Catheter Adapter<br>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

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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.