(90 days)
FlexiCap Disconnect Cap with Povidone-Iodine Solution (5C4456): 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.
MiniCap with Povidone-Iodine Solution (5C4466P): 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.
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.
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.
This document is a 510(k) premarket notification for two devices: the FlexiCap Disconnect Cap with Povidone-Iodine Solution and the MiniCap with Povidone-Iodine Solution, both manufactured by Baxter Healthcare Corporation.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All tests met the acceptance criteria" for both devices, but it does not specify the quantitative acceptance criteria themselves. It only lists the types of tests performed.
| Test Name | Acceptance Criteria (Not specified) | Reported Device Performance |
|---|---|---|
| Torque-On Test | (Not specified) | Met acceptance criteria |
| Leak Test | (Not specified) | Met acceptance criteria |
| Iodine Efficacy Test | (Not specified) | Met acceptance criteria |
| Cytotoxicity | (Not specified) | Met acceptance criteria |
| Irritation/Intracutaneous | (Not specified) | Met acceptance criteria |
| Sensitization | (Not specified) | Met acceptance criteria |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific test (Torque-On, Leak, Iodine Efficacy, Biocompatibility tests). It mentions "non-clinical tests" and "bench tests."
The data provenance is from non-clinical bench testing conducted by Baxter Healthcare Corporation. No information on country of origin for data or whether it's retrospective or prospective is provided for the non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the tests described are non-clinical bench tests (e.g., Torque-On, Leak, Iodine Efficacy, Biocompatibility). These types of tests do not typically involve human experts establishing ground truth in the same way clinical studies or image interpretation tasks would. The "ground truth" for these tests would be defined by the physical or chemical standards and specifications against which the devices are measured.
4. Adjudication method for the test set
This information is not applicable as the tests described are non-clinical bench tests. Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation or consensus is required (e.g., clinical trials, image reading).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This document describes the substantial equivalence of medical devices (disconnect caps for peritoneal dialysis) based on non-clinical performance and biocompatibility data, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is entirely outside the scope of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The devices are physical medical products and do not involve any algorithms or AI for standalone performance evaluation.
7. The type of ground truth used
For the non-clinical tests (Torque-On, Leak, Iodine Efficacy), the ground truth is based on pre-defined technical specifications and performance standards. These standards would dictate what constitutes an acceptable torque value, an acceptable leak rate, or an effective iodine concentration/release.
For Biocompatibility tests (Cytotoxicity, Irritation/Intracutaneous, Sensitization), the ground truth is established against standardized biological evaluation criteria, specifically ISO-10993 Part 1 and FDA Blue Book Memorandum #G95-1. These standards define the acceptable biological responses for device materials in contact with the body.
8. The sample size for the training set
This information is not applicable. The devices are physical products, not AI models that require a training set. The "training" in this context refers to manufacturing and quality control processes to meet specifications, not an algorithmic training set.
9. How the ground truth for the training set was established
This information is not applicable. As these are physical medical devices and not AI algorithms, there is no "training set" in the context of machine learning. The focus is on ensuring the manufactured products consistently meet established design specifications and performance criteria through quality control and testing processes.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 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) 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) | |
|---|---|
| ☑ 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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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: (224) 270-4343 Fax: (224) 270-4119
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 MiniCapwith Povidone-Iodine, High Dose DisconnectCap with Povidone-Iodine | Baxter HealthcareCorporation | 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: (224) 270-4343 Fax: (224) 270-4119
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 Codes5C4212 and 5C4466 | Baxter HealthcareCorporation | 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.
§ 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.