FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution

K152129 · Baxter Healthcare Corporation · KDJ · Oct 29, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K152129
• Device Name: FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution
• Applicant: Baxter Healthcare Corporation
• Product Code: KDJ · Gastroenterology, Urology
• Decision Date: Oct 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2

Intended Use

This device is intended for use in the treatment of patients with renal failure to isolate the Luer patient of the Baxter APD (Automated Peritoneal Dialysis) disposable set during temporary disconnections and during the dwell phase of therapy. This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodine intended to protect the female Luer connector of the Baxter transfer set.

Device Story

Single-use disconnect caps for peritoneal dialysis; designed to isolate and protect female Luer connectors of Baxter APD disposable or transfer sets during temporary disconnections and dwell phases. Device consists of molded low-density polyethylene cap containing polyurethane foam sponge saturated with 10% povidone-iodine (PVP-I) solution. Used by patients undergoing peritoneal dialysis therapy. Provides physical barrier and antiseptic environment to maintain sterility of connector during therapy intervals. Benefits include reduced risk of contamination during line disconnections.

Clinical Evidence

Bench testing only. Performance evaluated via torque-on, leak, and iodine efficacy tests. Biocompatibility testing conducted per ISO-10993 (cytotoxicity, irritation/intracutaneous, sensitization). All tests met acceptance criteria.

Technological Characteristics

Materials: Low density polyethylene cap, polyurethane foam sponge, 10% povidone-iodine solution. Form factor: Single-use plastic cap. Biocompatibility: ISO-10993 compliant. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients with renal failure undergoing peritoneal dialysis to isolate and protect the Luer connector of the Baxter APD disposable or transfer set during temporary disconnections and dwell phases.

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

• High Dose Disconnect Cap and MiniCap with Povidone-Iodine, High Dose Disconnect Cap with Povidone-Iodine (K972579)
• Disconnect Caps Product Codes 5C4212 and 5C4466 (K895631)

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 features a stylized image of an eagle or bird with three profiles facing right, suggesting a sense of forward movement and progress. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the bird symbol.

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

October 29, 2015

Baxter Healthcare Corporation Tiffany Lin Manager, Regulatory Affairs 32650 N. Wilson Road Round Lake, IL 60073

Re: K152129

> Trade/Device Name: FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution Regulation Number: 21 CFR§ 876.5630 Regulation Name: Periotoneal dialysis system and accessories Regulatory Class: II Product Code: KDJ Dated: July 30, 2015 Received: July 31, 2015

Dear Tiffany Lin,

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. Iisting 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ResourcesforYou/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) K152129

#### Device Name

FlexiCap Disconnect Cap with Povidone-Iodine Solution (5C4456)

Indications for Use (Describe)

This device is intended for use in the treatment of patients with renal failure to isolate the Luer patient of the Baxter APD (Automated Peritoneal Dialysis) disposable set during temporary disconnections and during the dwell phase of therapy.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

> 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 [e-mail]

"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) K152129

Device Name

MiniCap with Povidone-Iodine Solution (5C4466P)

Indications for Use (Describe)

This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodine intended to protect the female Luer connector of the Baxter transfer set.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <span style="font-size:12px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:12px;">☐</span> 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 [e-mail]

"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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Image /page/4/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 slanted to the right.

## Section 5. 510(k) Summary

July 30, 2015

#### OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

## CONTACT PERSON:

Tiffany Lin Manager, Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: [phone] Fax: [phone]

## IDENTIFICATION OF THE DEVICE:

Common Name: Disconnect Cap Trade Name or Proprietary Name: FlexiCap Disconnect Cap with Povidone-Iodine Solution (5C4456) Classification Panel: 78 Gastroenterology/Urology Classification: Set, Administration, For Peritoneal Dialysis, Disposable (21 CFR 876.5630) Class: Class II

Product Code: KDJ

## Table 1. Baxter Product Code

| Code Number | Name |
|-------------|-------------------------------------------------------|
| 5C4456 | FlexiCap Disconnect Cap with Povidone-Iodine Solution |

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Image /page/5/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The word is slightly blurred, giving it a sense of depth. The font is sans-serif and appears to be a company logo.

## PREDICATE DEVICE:

| Device | Company | Predicate 510(k) | Clearance Date |
|----------------------------------------------------------------------------------------------------------------|----------------------------------|------------------|-----------------|
| High Dose Disconnect Cap and MiniCap<br>with Povidone-Iodine, High Dose Disconnect<br>Cap with Povidone-Iodine | Baxter Healthcare<br>Corporation | K972579 | October 1, 1997 |

#### Table 2. Predicate Device

## DESCRIPTION OF THE DEVICE:

The FlexiCap Disconnect Cap with Povidone-Iodine Solution (FlexiCap) is a single use device that connects to the patient line connector of the Baxter Automated Peritoneal Dialysis (APD) set and is designed to isolate the line during temporary disconnections and the dwell phase of peritoneal dialysis therapy sessions. The FlexiCap consists of a molded low density polyethylene cap which contains a polyurethane foam sponge and 10% povidone-iodine (PVP-I) solution.

## INDICATIONS FOR USE:

#### Device Name:

FlexiCap Disconnect Cap with Povidone-Iodine Solution (5C4456)

#### Indications for Use:

This device is intended for use in the treatment of patients with renal failure to isolate the Luer patient line connector of the Baxter APD (Automated Peritoneal Dialysis) disposable set during temporary disconnections and during the dwell phase of therapy.

#### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The proposed device has equivalent technological characteristics as Baxter's currently legally marketed FlexiCap cleared under 510(k) premarket notification K972579 (cleared October 1, 1997). The intended use, design and function of the proposed device are equivalent to the predicate device.

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Image /page/6/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 blurred, giving it a sense of depth.

## DISCUSSION OF NONCLINICAL TESTS:

Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet their acceptance criteria and support that the proposed device is appropriately designed for its intended use.

#### Performance Data:

The following bench tests were conducted to evaluate the functional performance of the FlexiCap:

- . Torque-On Test
- Leak Test
- . Iodine Efficacy Test

All tests met the acceptance criteria.

#### Biocompatibility:

No new materials of construction are being introduced into the FlexiCap. Materials found in the FlexiCap have been previously cleared under 510(k) premarket notification K972579 (cleared October 1, 1997).

Biocompatibility assessments for the FlexiCap were conducted in accordance with ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," for Surface Device, Skin Contact, Permanent Contact Duration, and FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993." The battery of testing included the following tests:

- Cytotoxicity
- Irritation/Intracutaneous ●
- . Sensitization

## CONCLUSION:

The non-clinical data support the safety of the proposed device and demonstrate that the proposed device performs 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 is slightly italicized, giving the word a sense of movement. The word is the logo for the healthcare company Baxter International.

## Section 5. 510(k) Summary

July 30, 2015

#### OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

# CONTACT PERSON:

Tiffany Lin Manager, Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: [phone] Fax: [phone]

## IDENTIFICATION OF THE DEVICE:

Common Name: Disconnect Cap Trade Name or Proprietary Name: MiniCap with Povidone-Iodine Solution (5C4466P) Classification Panel: 78 Gastroenterology/Urology Classification: Set, Administration, For Peritoneal Dialysis, Disposable (21 CFR 876.5630) Class: Class II

Product Code: KDJ

| Table 1. Baxter Product Code | |
|------------------------------|--|
|------------------------------|--|

| Code Number | Name |
|-------------|---------------------------------------|
| 5C4466P | MiniCap with Povidone-Iodine Solution |

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Image /page/8/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The word is slightly italicized, giving it a sense of movement. The font is sans-serif and appears to be a custom typeface designed for the company's logo.

## PREDICATE DEVICE:

| Device | Company | Predicate 510(k) | Clearance Date |
|----------------------------------------------------|----------------------------------|------------------|------------------|
| Disconnect Caps Product Codes<br>5C4212 and 5C4466 | Baxter Healthcare<br>Corporation | K895631 | January 29, 1990 |

#### Table 2. Predicate Device

## DESCRIPTION OF THE DEVICE:

The MiniCap with Povidone-Iodine Solution (MiniCap) is a single use device that connects to a Baxter transfer set and is designed to isolate the line between peritoneal dialysis therapy sessions. The MiniCap consists of a molded low density polyethylene cap which contains a polyurethane foam sponge and 10% Povidone-Iodine (PVP-I) solution.

## INDICATIONS FOR USE:

Device Name: MiniCap with Povidone-Iodine Solution (5C4466P)

#### Indications for Use:

This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodine intended to protect the female Luer connector of the Baxter transfer set.

## TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The proposed device has equivalent technological characteristics as Baxter's currently legally marketed MiniCap cleared under 510(k) premarket notification K895631 (cleared January 29, 1990). The intended use, design and function of the proposed device are equivalent to the predicate device.

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Image /page/9/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The letters are slightly slanted to the right, giving the word a sense of movement. The font is sans-serif, and the letters are evenly spaced. The overall impression is one of a strong and reliable brand.

## DISCUSSION OF NONCLINICAL TESTS:

Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet their acceptance criteria and support that the proposed device is appropriately designed for its intended use.

## Performance Data:

The following bench tests were conducted to evaluate the functional performance of the MiniCap:

- . Torque-On Test
- Leak Test
- . Iodine Efficacy Test

All tests met the acceptance criteria.

#### Biocompatibility:

No new materials of construction are being introduced into the MiniCap. Materials found in the MiniCap have been previously cleared under 510(k) premarket notification K895631 (cleared January 29, 1990).

Biocompatibility assessments for the MiniCap were conducted in accordance with ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," for Surface Device, Skin Contact, Permanent Contact Duration, and FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993." The battery of testing included the following tests:

- Cytotoxicity
- Irritation/Intracutaneous ●
- . Sensitization

## CONCLUSION:

The non-clinical data support the safety of the proposed device and demonstrate that the proposed device performs comparably to the predicate device that is currently marketed for the same intended use.