(86 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functionality of a drainage bag for peritoneal dialysis, with no mention of AI or ML.
No
The device is a drainage bag used for the collection of effluent during APD therapy; it does not directly treat or diagnose a disease or condition, but rather assists in the execution of the therapy.
No
The device is a collection bag for effluent during peritoneal dialysis and does not perform any diagnostic functions. It is used for collecting waste fluid, not for analyzing or interpreting patient conditions.
No
The device is a physical drainage bag for collecting effluent during dialysis, not a software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "collection of effluent during Automated Peritoneal Dialysis (APD) Therapy." This is a collection device for waste fluid from a medical procedure, not a device used to perform tests on biological samples to diagnose or monitor a medical condition.
- Device Description: The description reinforces its function as a collection bag for spent effluent. It explicitly states it does not come into direct or indirect contact with the patient's body tissue.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing diagnostic or monitoring information about a patient's health status
The device is a medical device used in the context of a therapy, but its function is purely for containment of waste, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
This bag is intended for the collection of effluent during Automated Peritoneal Dialysis (APD) Therapy.
Product codes (comma separated list FDA assigned to the subject device)
KDJ
Device Description
Baxter's Cycler Drainage Bag product line currently consists of a sterile 15L Cycler Drainage Bag (5C4145P). This 15 L Cycler Drainage Bag is a single use device intended for the collection of effluent during Automated Peritoneal Dialysis (APD) Therapy and can be used with Baxter's APD Sets with Cassette, Manifold Sets and Extension Sets. The purpose of this drain bag is to allow the collection of the spent effluent in the event that a patient does not have access to a drain from the location where APD therapy is performed. This product line has been previously cleared under 510(k) premarket notification K791899 (cleared on November 13, 1979).
The basis for this submission is the addition of a non-sterile version of the 15L Cycler Drainage Bag to the current product line. The product line does not come into direct or indirect contact with the patient's body tissue. The intended use, material, design, and function of the proposed device will be the same as the currently marketed 15 L Cycler Drainage Bag.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Baxter Healthcare Corporation conducts risk analyses to determine the design verification tests that need to be conducted based on the proposed change. All results meet the acceptance criteria, and support that the devices presented in this premarket notification are appropriately designed for their intended use. Performance data includes:
- Capacity/Leak Test:
- 5C4145P: The product shall hold 16 liters of water for 24 hours without leak.
- 5C4145NS: The product shall hold 16 liters of water for 48 hours without leak.
- Drain Line Spike/Leak Test: 5C4145P, 5C4145NS: Force to spike drain line connector shall be no more than 35 lbf with no leak at 8 psig for 10 seconds.
- Drain Line Spike Removal Test:
- 5C4145P: Force to remove spike connector after a 24-hour therapy shall be no less than 3 lbf.
- 5C4145NS: Force to remove spike connector after a 48-hour therapy shall be no less than 3 lbf.
- Clamp Closure Force Test: 5C4145P, 5C4145NS: Manual shut-off clamp closure force on tubing lines shall be no more than 26 lbf.
- Clamp Opening Force Test: 5C4145P, 5C4145NS: Manual shut-off clamps on lines shall open with a force no more than 10 lbf.
- Bioburden Measurement Test: 5C4145P, 5C4145NS: The drain bag shall have less than or equal to 100 CFUs per set.
- Microbial Travel Test: 5C4145NS: Upper boundaries for bacterial travel distance for both ascending and descending positions at 35-39℃ after 48 hours are less than the distance required to contaminate the APD cassette.
- Cycler System Level Test: 5C4145NS: For both the HomeChoice and HomeChoice Claria cyclers: Under least favorable conditions, the drain flow rate lower bound > 50ml/min.
- Spike Tip Protector Removal Force Test: 5C4145P: The axial force to remove the spike tip protector shall not be less than 4.5 N (1.0 lbf) or greater than 45 N (10.0 lbf).
- Pull Ring Tip Protector Removal Force Test: 5C4145P: The axial force to remove the pull ring tip protector shall not be less than 4.5 N (1.0 lbf) or greater than 54 N (12.0 lbf).
- Solvent Bond Leak Strength Test: 5C4145P: The subsystem, after being subjected to a 5 lbf pull force shall not leak when subjected to 8 psig pressure for 10 seconds.
- Connection Duration Test: 5C4145P: Drain bag and APD sets connected after 48 hours.
Biocompatibility: The biocompatibility evaluation was conducted in accordance with ISO-10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. The device is classified as "non-contact" in accordance with FDA Guidance Document Use of International Standard ISO 10993-1.
Sterilization: The sterile version (5C4145P) is sterilized with ethylene oxide (EO) gas to a 106 Sterility Assurance Level (SAL), compliant with ANSI/AAMI ST67:2019 and ANSI/AAMI/ISO 11135-1:2014.
Shelf Life: Aging testing supports a shelf-life claim of 5 (five) years.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA 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.
March 18, 2022
Baxter Healthcare Corporation c/o Maninee Patel Associate Director, Regulatory Affairs One Baxter Parkway Deerfield, Illinois 60015
Re: Trade/Device Name: 15L Cycler Drainage Bag Regulation Number: 21 CFR 876.5630 Regulation Name: Peritoneal Dialysis System And Accessories Regulatory Class: II Product Code: KDJ Received: December 22, 2021
Dear Maninee Patel:
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 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
1
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Gema Gonzalez Acting 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
ADDITIONAL CONSIDERATIONS
The following are FDA suggestions, recommendations, or requests that did not preclude a favorable decision on the marketing application. A complete response to additional considerations is not required.
Sterility
In Appendix 14-2, you provided a test report for accelerated aging using the sterile version of your Drainage Bag. However, in this test report you have stated that the Q10 was equal to 3. Per ASTM F1980-16, "Using the Arrhenius equation with Q10 equal to 2 is a common and conservative means of calculating an aging factor. NOTE 6-A more aggressive reaction rate coefficient, for example, Q10 = 2.2 to 2.5, may be used if the system under investigation is sufficiently well characterized in the literature. The level and nature of damage must be similar to that reported in the literature to ensure that the reaction rate coefficient and accelerated aging temperature are maintained within appropriate boundaries. This is the responsibility of the manufacturer." Therefore, it is recommended that the Q10 equal 2 for accelerated aging to support packaging. In future submissions, please conduct accelerated aging using a 010 equal to 2.
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K214016
Device Name 15L Cycler Drainage Bag
Indications for Use (Describe)
This bag is intended for the collection of effluent during Automated Peritoneal Dialysis (APD) 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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Image /page/4/Picture/1 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and appears to be italicized. The word is the logo for the healthcare company Baxter International.
510(k) Summary
September 30, 2021
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Maninee Patel, PharmD Associate Director, Global Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: (224)217-7875
IDENTIFICATION OF THE DEVICE:
Common Name: Peritoneal dialysis system and accessories Trade/Device Name: 15L Cycler Drainage Bag Classification Panel: Gastroenterology/Urology Regulation Number: 21 CFR 876.5630 Regulation Name: Peritoneal Dialysis Tubing Kit Product Code: KDJ
| Product Code | Description |
|---|---|
| 5C4145P (currently marketed) | 15L Cycler Drainage Bag (sterile) |
| 5C4145NS (proposed) | 15L Cycler Drainage Bag (non-sterile) |
Table 1. Current and Proposed Device Configuration
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Image /page/5/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.
PREDICATE DEVICE:
| Device | Company | Predicate 510(k) | Clearance Date | Product Codes |
|---|---|---|---|---|
| Cycler | ||||
| Drainage Set | ||||
| 15L Cycler | ||||
| Drainage | ||||
| Bag | ||||
| (currently | ||||
| marketed) | Baxter Healthcare | |||
| Corporation | ||||
| (Submitted by | ||||
| Travenol | ||||
| Laboratories) | K791899 | November 13, 1979 | 5C4145 | |
| 5C4145P | ||||
| (currently | ||||
| marketed) |
Table 2. Predicate Device
DESCRIPTION OF THE DEVICE:
Baxter's Cycler Drainage Bag product line currently consists of a sterile 15L Cycler Drainage Bag (5C4145P). This 15 L Cycler Drainage Bag is a single use device intended for the collection of effluent during Automated Peritoneal Dialysis (APD) Therapy and can be used with Baxter's APD Sets with Cassette, Manifold Sets and Extension Sets. The purpose of this drain bag is to allow the collection of the spent effluent in the event that a patient does not have access to a drain from the location where APD therapy is performed. This product line has been previously cleared under 510(k) premarket notification K791899 (cleared on November 13, 1979).
The basis for this submission is the addition of a non-sterile version of the 15L Cycler Drainage Bag to the current product line. The product line does not come into direct or indirect contact with the patient's body tissue. The intended use, material, design, and function of the proposed device will be the same as the currently marketed 15 L Cycler Drainage Bag.
INDICATIONS FOR USE:
This bag is intended for the collection of effluent during APD Therapy.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
In Table 3, the proposed device (5C4145NS) is compared to the currently marketed version of the predicate device (5C4145P).
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| | Features | Predicate Device
15L Cycler Drainage
Bag
( Product Code:
5C4145P – currently
marketed) | Proposed
Device
15L Cycler
Drainage Bag
(Product Code:
5C4145NS) | Assessment of Differences |
|--------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Indications for
Use | This bag is intended for
the collection of effluent
during APD Therapy. | Same | Not Applicable |
| | Sterile and Non-
Pyrogenic | Yes | No | Sterilization of the drain bag is not
required for the patient to perform
therapy and collect effluent safely.
Testing demonstrates that control
of product bioburden, the length of
the drain line, and the flow rate of
spent dialysate adequately mitigate
the risk of contamination of the
patient peritoneum from pathogens
originating in the drain bag.
Instructions for Use were updated
accordingly to ensure no increased
risk for patient. |
| | Pump
Compatibility and
Electromechanical
Device
Compatibility | Homechoice,
Homechoice Claria, and
Amia | Same | Not Applicable |
| | Single Use | Yes | Same | Not Applicable |
| | Materials | | | |
| | Drain Bag
Inlet and
Outlet Tubing | Polyvinyl Chloride
(PVC) | | |
| | Outlet Clamp | Polypropylene (PP) | | |
| | Inlet Clamp | High Density
Polyethylene (HDPE) | Same | Not Applicable |
| | Drain Line
Adapter | Acrylonitrile Butadiene
Styrene (ABS) | | |
| | Spike
Connector | ABS | | |
| | Pull Ring Cap | Low Density
Polyethylene (LDPE) | Same | Not Applicable |
| | Tip Protector | LDPE | | |
| Features | Predicate Device
15L Cycler Drainage
Bag
(Product Code:
5C4145P – currently
marketed) | Proposed Device
15L Cycler
Drainage Bag
(Product Code:
5C4145NS) | Assessment of Differences | |
| Flow Wrap
Pouch | HDPE Film | | | |
| Carton | Corrugated Cardboard | | | |
Table 3. Device Comparison
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Table 3. Device Comparison
DISCUSSION OF NONCLINICAL TESTS:
Baxter Healthcare Corporation conducts risk analyses to determine the design verification tests that need to be conducted based on the proposed change. All results meet the acceptance criteria, and support that the devices presented in this premarket notification are appropriately designed for their intended use.
| Table 4. Peformance Data | ||
|---|---|---|
| Test | Product | |
| Code Tested | Requirements | |
| Capacity/Leak | 5C4145P | The product shall hold 16 liters of water for 24 hours without |
| leak. | ||
| 5C4145NS | The product shall hold 16 liters of water for 48 hours without | |
| leak. | ||
| Drain Line Spike/Leak | 5C4145P, | |
| 5C4145NS | Force to spike drain line connector shall be no more than 35 | |
| lbf with no leak at 8psig for 10 seconds. | ||
| Drain Line Spike | ||
| Removal | 5C4145P | Force to remove spike connector after a 24-hour therapy |
| shall be no less than 3 lbf. | ||
| 5C4145NS | Force to remove spike connector after a 48-hour therapy | |
| shall be no less than 3 lbf. | ||
| Clamp Closure Force | 5C4145P, | |
| 5C4145NS | Manual shut-off clamp closure force on tubing lines shall be | |
| no more than 26 lbf. | ||
| Clamp Opening Force | 5C4145P, | |
| 5C4145NS | Manual shut-off clamps on lines shall open with a force no | |
| more than 10 lbf. | ||
| Bioburden | ||
| Measurement | 5C4145P, | |
| 5C4145NS | The drain bag shall have less than or equal to 100 CFUs per | |
| set. |
Performance Data:
8
Baxter
| Table 4. Peformance Data | |||
|---|---|---|---|
| Test | Product | ||
| Code Tested | Requirements | ||
| Microbial Travel | 5C4145NS | Upper boundaries for bacterial travel distance for both | |
| ascending and descending positions at 35-39℃ after 48 | |||
| hours are less than the distance required to contaminate the | |||
| APD cassette. | |||
| Cycler System Level | 5C4145NS | For both the HomeChoice and HomeChoice Claria cyclers: | |
| Under least favorable conditions, the drain flow rate lower | |||
| bound > 50ml/min. | |||
| Spike Tip Protector | |||
| Removal Force | 5C4145P | The axial force to remove the spike tip protector shall not be | |
| less than 4.5 N (1.0 lbf) or greater than 45 N (10.0 lbf). | |||
| Pull Ring Tip Protector | |||
| Removal Force | 5C4145P | The axial force to remove the pull ring tip protector shall not | |
| be less than 4.5 N (1.0 lbf) or greater than 54 N (12.0 lbf). | |||
| Solvent Bond Leak | |||
| Strength | 5C4145P | The subsystem, after being subjected to a 5 lbf pull force | |
| shall not leak when subjected to 8 psig pressure for 10 | |||
| seconds. | |||
| Connection Duration | |||
| Test | 5C4145P | Drain bag and APD sets connected after 48 hours. |
Biocompatibility:
The biocompatibility evaluation of this product line was conducted in accordance with ISO-10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, as recognized by the FDA. The 15L Cycler Drainage Bags presented in this premarket notification do not come into direct or indirect contact with the patient's body tissue and are classified as "non-contact" in accordance with 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 Sept 4, 2020).
Sterilization:
The sterile version of the 15L Cycler Drainage Bag (5C4145P) is sterilized with ethylene oxide (EO) gas. The product is in the bioburden (sub) category "Bag Device labeled sterile fluid path". The EO cycles used on this product to provide a 106 Sterility Assurance Level (SAL) for this (sub) category were established and validated at the manufacturing facilities as described in ANSI/AAMI ST67:2019 Sterilization of Health Care Products - requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile". Requirements for products labeled 'sterile' and the sterilization process for the proposed device are also compliant to ANSI/A AMI/ISO 11135-1:2014 Sterilization of Health Care Products - Ethylene Oxide - Part 1:
9
Haxter
Requirements for development, validation, and routine control of sterilization process for medical devices.
Shelf Life:
Baxter has performed aging testing to support a shelf-life claim of 5 (five) years.
CONCLUSION:
The non-clinical data demonstrate that the proposed device is substantially equivalent and performs comparably to the predicate device that is legally marketed for the same intended use.