EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER

K152675 · Baxter Healthcare · KDJ · Oct 29, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K152675
• Device Name: EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER
• Applicant: Baxter Healthcare
• Product Code: KDJ · Gastroenterology, Urology
• Decision Date: Oct 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MiniCap Extended Life PD Transfer Sets: This set is used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient from the source solution container. Locking Titanium Adapter: The Locking Titanium Adapter for Peritoneal Dialysis Catheter is intended to secure the peritoneal catheter tubing to the Baxter transfer set used during Peritoneal Dialysis therapy. Locking Cap: This device is indicated for use in the treatment of patients receiving perioneal dialysis therapy, to cap the Locking Titanium Adapter for Peritoneal Dialysis Catheter Transfer Set installations.

Device Story

Single-use, sterile, non-pyrogenic peritoneal dialysis (PD) accessories; includes transfer sets, locking titanium adapters, and locking caps. Transfer sets connect source solution containers to implanted peritoneal catheters; allow solution exchange into/out of peritoneal cavity. Titanium adapter secures catheter tubing to transfer set; locking cap seals adapter between installations. Used in clinical or home settings by patients or caregivers. Devices facilitate PD therapy delivery; ensure secure, leak-free fluid path. Biocompatible materials evaluated per ISO-10993 for permanent duration, external communicating, indirect blood path contact.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included leak tests, torque tests (open/close/on/off), tensile pull tests, and flow tests. Biocompatibility testing conducted per ISO-10993, including cytotoxicity, systemic toxicity, irritation, sensitization, and hemocompatibility.

Technological Characteristics

Materials evaluated for permanent duration, external communicating, indirect blood path contact per ISO-10993. Components include titanium adapters, locking caps, and transfer sets with twist clamps. Mechanical design features luer connections and torque-based locking mechanisms. Sterile, non-pyrogenic, single-use. No software or energy source.

Indications for Use

Indicated for patients receiving peritoneal dialysis therapy requiring transfer of dialysis solution to the patient catheter or capping of the titanium adapter between transfer set installations.

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

• Extended Life CAPD Transfer Set 5C4444 (K882498)
• Peritoneal Dialysis Titanium Catheter Adapter and Locking Cap for Titanium Adapter - Product Codes 5C4168 and 5C4169 (K894783)

Reference Devices

• HomeChoice Adult Set
• HomeChoice Pediatric Set
• Twin Bag Set
• Ultra Bag Set
• Y-Set

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with a stylized design that suggests flowing hair or water beneath the profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 29, 2015

Baxter Healthcare Corporation John Lamela Specialist, Regulatory Affairs 32650 N. Wilson Road Round Lake, IL 60073

Re: K152675

> Trade/Device Name: MiniCap Extended Life PD Transfer Sets, Locking Titanium Adapter for Peritoneal Dialysis Catheter and Locking Cap for Peritoneal Dialysis Catheter Adapter Regulation Number: 21 CFR§ 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: KDJ Dated: September 17, 2015 Received: September 18, 2015

Dear John Lamela,

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, 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 statutes and regulations administered by other Federal agencies.

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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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K152675

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.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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# Indications for Use

510(k) Number (if known)

K152675

#### Device Name

Locking Titanium Adapter for Peritoneal Dialysis Catheter and Locking Cap for Peritoneal Dialysis Catheter Adapter

Indications for Use (Describe)

Titanium Adapter: The Locking Titanium Adapter for Peritoneal Dialysis Catheter is intended to secure the peritoneal catheter tubing to the Baxter transfer set used during Peritoneal Dialysis therapy.

Locking Cap: This device is indicated for use in the treatment of patients receiving perioneal dialysis therapy, to cap the Locking Titanium Adapter for Peritoneal Dialysis Catheter Transfer Set installations.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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## Section 5. 510(k) Summary

Sept. 17, 2015

#### OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

## CONTACT PERSON:

John Lamela Specialist, Global Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: [phone] Fax: [phone]

## 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 (21 CFR 876.5630) Class: II Product Code: KDJ

| Code Number | Name |
|-------------|-------------------------------------------------------------------------|
| 5C4482 | MiniCap Extended Life PD Transfer Set with Twist<br>Clamp |
| 5C4483 | MiniCap Extended Life PD Transfer Set with Twist<br>Clamp - Extra Short |

#### Table 1. Product Code(s) for Transfer Sets

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## PREDICATE DEVICE:

| Device | Company | Predicate 510(k) | Clearance Date |
|-------------------------------------------|----------------------------------|------------------|----------------|
| Extended Life CAPD<br>Transfer Set 5C4444 | Baxter Healthcare<br>Corporation | K882498 | 07/13/1988 |

#### Table 2. Predicate Device(s)

#### 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 K882498 (cleared on July 13, 1988). The intended use, design and function of the proposed devices are equivalent to the predicate device.

## DISCUSSION OF NONCLINICAL TESTS:

Baxter Healthcare Corporation conducts risk analysis and design verification tests based on the result of the nonclinical tests. All results meet their acceptance criteria, and support 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 devices:

- Leak Test Twist Clamp Closed ●
- Twist Clamp Torque to Open/Close ●

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Image /page/6/Picture/0 description: The image features the word "Baxter" in a bold, blue font. The font appears to be sans-serif, and the letters are closely spaced together. The overall impression is one of a strong and established brand.

- Leak Test Transfer Set to Patient Connector (HomeChoice Adult Set, . HomeChoice Pediatric Set, Twin Bag Set, Ultra Bag Set, Y-Set)
- Patient Connector Torque On to Transfer Set (HomeChoice Adult Set, ● HomeChoice Pediatric Set, Twin Bag Set, Ultra Bag Set, Y-Set)
- Patient Connector Torque Off from Transfer Set ●
- MiniCap Test Attachment Torque On/Off to Transfer Set ●
- Leak Test MiniCap to Transfer Set ●
- Flow Test CAPD Therapy and APD Therapy o

## 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 permanent 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 Blue Book Memorandum #G95-1, "Use of International Standard ISO-10993". The battery of testing included:

- Cytotoxicity
- Systemic Toxicity (Acute and Sub-chronic) ●
- Irritation (Intracutaneous Reactivity) ●
- Sensitization ●
- Hemocompatibility ●

## 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.

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Image /page/7/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly italicized, giving it a sense of movement.

## Section 5. 510(k) Summary

Sept. 16, 2015

#### OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

#### CONTACT PERSON:

John Lamela Specialist, Global Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: [phone] Fax: [phone]

## IDENTIFICATION OF THE DEVICE:

Common Name: Titanium Adapter and Locking Cap Trade Name or Proprietary Name: Locking Titanium Adapter for Peritoneal Dialysis Catheter and Locking Cap for Peritoneal Dialysis Catheter Adapter Classification Panel: 78 Gastroenterology/Urology Classification: Set, Administration, For Peritoneal Dialysis, Disposable (21 CFR 876.5630) Class: II Product Code: KDJ

| Code Number | Name |
|-------------|--------------------------------------------------------------|
| 5C4129 | Locking Titanium Adapter for Peritoneal Dialysis<br>Catheter |
| 5C4169 | Locking Cap for Peritoneal Dialysis Catheter<br>Adapter |

#### Table 1. Product Code(s)

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## PREDICATE DEVICE:

| Device | Company | Predicate 510(k) | Clearance Date |
|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|------------------|-------------------|
| Peritoneal Dialysis<br>Titanium Catheter<br>Adapter and Locking<br>Cap for Titanium<br>Adapter - Product<br>Codes 5C4168 and<br>5C4169 | Baxter Healthcare<br>Corporation | K894783 | September 7, 1989 |

## Table 2. Predicate Device(s)

## DESCRIPTION OF THE DEVICE:

The Locking Titanium Adapter for Peritoneal Dialysis Catheter (Titanium Adapter) and Locking Cap for Peritoneal Dialysis Catheter (Locking Cap) are single use, sterile, non-pyrogenic devices for use with Baxter peritoneal dialysis systems. The Titanium Adapter is a device that is secured to the end of a peritoneal dialysis catheter and is used to connect the peritoneal dialysis catheter to the Transfer Sets. The Locking Cap is used to cap the end of the Titanium Adapter between Transfer Set installations.

## INDICATIONS FOR USE:

Titanium Adapter: The Locking Titanium Adapter for Peritoneal Dialysis Catheter is intended to secure the peritoneal catheter tubing to the Baxter transfer set used during Peritoneal Dialysis therapy.

Locking Cap: This device is indicated for use in the treatment of patients receiving peritoneal dialysis therapy, to cap the Locking Titanium Adapter for Peritoneal Dialysis Catheter between Baxter Transfer Set installations.

## TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The proposed devices have equivalent technological characteristics as Baxter's currently legally marketed Titanium Adapter and Locking Cap cleared under 510(k) premarket notification K894783 (cleared on August 7, 1989). The intended use, design and function of the proposed devices are equivalent to the predicate device.

# DISCUSSION OF NONCLINICAL TESTS:

Baxter Healthcare Corporation conducts risk analysis and design verification tests based on the result of the nonclinical tests. 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/9/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly italicized, giving it a sense of movement.

## Performance Data:

The following functional testing was performed to ensure proper design and function of the devices:

- Titanium Adapter/Patient Catheter Tubing Seal Test
- Tensile Pull Test Titanium Adapter to Patient Catheter Tubing ●
- Locking Cap Removal Torque Test ●
- Locking Cap Torque On Test .
- Tensile Strength Adapter Catheter to Luer End of Titanium Adapter .
- Adapter Catheter to Titanium Adapter - Torque On Test
- Adapter Catheter to Titanium Adapter - Torque Off Test
- Leak Test Adapter Catheter to Titanium Adapter ●
- . Simulation Testing

## 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 permanent 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 Blue Book Memorandum #G95-1, "Use of International Standard ISO-10993". The battery of testing included:

- Cytotoxicity
- Systemic Toxicity (Acute and Sub-chronic) ●
- . Irritation (Intracutaneous Reactivity)
- Sensitization ●
- Hemocompatibility

## 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.