(90 days)
Not Found
No
The device description and performance studies indicate a passive, mechanical drainage system with no mention of AI or ML capabilities.
No
This device is a cycler drain bag set used to collect patient effluent during peritoneal dialysis and does not appear to directly treat a disease or condition.
No
The device collects patient effluent during peritoneal dialysis and does not perform any diagnostic function.
No
The device description explicitly details physical components like tubing, flexible bags, sampling ports, and clamps, and the performance studies focus on physical properties and integrity, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to collect patient effluent during peritoneal dialysis. This is a process of removing waste products from the body, not a diagnostic test performed on a sample in vitro (outside the body).
- Device Description: The device is a passive drainage system for collecting fluid. It does not involve any reagents, analysis of biological samples, or diagnostic procedures.
- Lack of Diagnostic Elements: There is no mention of analyzing the collected effluent for diagnostic purposes. The focus is solely on collection and disposal.
- Predicate Device: The predicate device is a "Peritoneal Dialysis Drainage Set," which aligns with the function of collecting fluid during dialysis, not performing a diagnostic test.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) to diagnose diseases or conditions. This device's function is purely for fluid management during a medical treatment.
N/A
Intended Use / Indications for Use
The Cycler Drain Bag Set is indicated for use by patients with acute and stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The Cycler Drain Bag Set is an optional receptacle that connects to the Luer-lock end of a Cycler Set drain line in order to collect patient effluent during PD treatments. This device is to be used only with Fresenius Medical Care (FMCNA) Cyclers and Cycler Sets.
Product codes
KDJ
Device Description
The Drain Bag Set is a new, single-use device designed to collect patient effluent during the drain phase of an Automated Peritoneal Dialysis (APD) treatment. The Drain Bag Set is provided sterile and non-pyrogenic. The Drain Bag Set is sterilized using ethylene oxide (EO). The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain Bag Set is used to collect effluent in bags rather than letting the effluent flow directly to a drain. The Drain Bag Set connects to the drain line of a cycler set to collect patient effluent by means of gravity and the pumping action of a Peritoneal Dialysis (PD) cycler. The Drain Bag Set connects to the drain line using a standard Luer lock connection. The Drain Bag Set consists of three (3) interconnected 7-liter drain bags, each with a sampling port and an occluding clamp. The tubing lines that connect each drain bag to the drain line have a snap-disconnect tubing segment. This tubing segment allows the user to disconnect individual bags by snapping the tubing apart.
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
The Drain Bag Set is used in both healthcare and home environments.
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)
A summary of testing conducted to support the determination of substantial equivalence is as follows:
- Drop Test: The drain bag was filled to capacity with water and dropped from a height of 0.25 m. The test was performed in accordance with ISO 15747:2010 Plastic Containers for Intravenous Injections. Results: Pass, results within acceptance criteria.
- Internal Pressure Test: The drain bags were exposed to an internal pressure of 50 kPa between two plane parallel plates maintaining the pressure for 15 minutes. The test was performed in accordance with ISO 15747:2010 Plastic Containers for Intravenous Injections. Results: Pass, results within acceptance criteria.
- Hanger Holes Tensile Strength: The drain bags were filled to capacity with water and were hung on a medical hooking pole by attaching a load of 3.5 lbs (15 N) for 60 minutes. The test was performed in accordance with ISO 15747:2010 Plastic Containers for Intravenous Injections. Results: Pass, results within acceptance criteria.
- Film Roughness Test: The drain bag film roughness was measured in three different locations – bottom, middle, and top of the bag– with a roughness meter. Results: Pass, results within acceptance criteria.
- Tensile Strength of Bonding Engagements: A pull-off test was performed using the applicable fixture for each bonded engagement with the Instron machine. Results: Pass, results within acceptance criteria.
- Maintenance of Sterility testing: The vented cap was validated as a sterile barrier via the dust drum microbial challenge test per ANSI/AAMI/ISO 11607-1:2006/(R) 2010 - A1:2014 Packaging for terminally sterilized medical devices –Part 1: Requirements for materials, sterile barrier systems, and packaging. Results: Pass, results within acceptance criteria.
- Male Luer lock connector testing: The eight (8) Male Luer lock connector tests were performed in accordance with ISO 594-2:1998 Conical Fittings with 6% (Luer) Taper for Syringes, Needles and certain other Medical Equipment. Part 2: Local Fittings standard. Results: Pass, results within acceptance criteria.
- Drain Bag Set Capacity: The drain bags were filled to capacity with water and it was observed if they were able to contain such volume. Results: Pass, results within acceptance criteria.
- Sampling Port (i.e., injection site) Leakage Test: The sampling port was punctured using a 23 gauge needle for 15 seconds and was then exposed to an internal air pressure of 20 kPa. The samples were submerged in water for 15 seconds and air leakages were inspected. The test was performed in accordance with ISO 15747:2010 Plastic Containers for Intravenous Injections. Results: Pass, results within acceptance criteria.
- Snap Connector Breakage Test: The snap connector was placed in a poka-yoke mechanism and subjected to a compression test with the Instron machine starting from the injection point (0°) and testing at 90°, 180°, and 270°. Results: Pass, results within acceptance criteria.
- Clamp Test: After activating the clamp on the tubing, the tubing was submerged and pressurized to 15 psi for 10 minutes. Any leaks past the clamp were observed. This test method was adopted from ISO 8638:2010 Section 5.5.1.1. Results: Pass, results within acceptance criteria.
- Vibratory (ship) Testing: A simulated shipping distribution test was performed using rotary motion. The package was exposed to repetitive shocks for a period of 60 minutes with a frequency of 270 cycles per minute. The test was performed in accordance with ASTM D4169-14 Standard Practice for Performance Testing of Shipping Containers and Systems. Results: Pass, results within acceptance criteria.
Results of the design verification tests met the design requirements for the proposed device and demonstrated that, like the predicate device, it is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 & Drug Administration (FDA). On the left is the Department of Health & Human Services 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.
January 24, 2018
Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, MA 02451
Re: K173363
Trade/Device Name: Cycler Drain Bag Set Regulation Number: 21 CFR& 876.5630 Regulation Name: Peritoneal Dialysis System and Accessories Regulatory Class: II Product Code: KDJ Dated: October 25, 2017 Received: October 26, 2017
Dear Denise Oppermann:
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.
1
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); 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold, sans-serif font. The text is black and appears to be centered on a white background. The letters are well-defined and easy to read.
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
2
Indications for Use
510(k) Number (if known) K173363
Device Name Cycler Drain Bag Set
Indications for Use (Describe)
The Cycler Drain Bag Set is indicated for use by patients with acute and stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The Cycler Drain Bag Set is an optional receptacle that connects to the Luer-lock end of a Cycler Set drain line in order to collect patient effluent during PD treatments. This device is to be used only with Fresenius Medical Care (FMCNA) Cyclers and Cycler Sets.
| 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) |
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Image /page/3/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line. The entire logo is in blue.
510(K) SUMMARY ട.
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR §807.92.
5.1. Submitter's Information
| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|---|---|
| Address: | 920 Winter Street |
| Waltham, MA | |
| 02451-1457 | |
| Phone: | (781) 699-4479 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann |
| Senior Director Regulatory Affairs – Devices | |
| Preparation Date: | October 27, 2017 |
5.2. Device Name
| Trade Name: | Cycler Drain Bag Set |
|---|---|
| Common Name: | Drain Bag Set |
| Classification Name: | Peritoneal Dialysis System and Accessories |
| Regulatory Class: | Class II per 21 CFR §876.5630 |
| Product Code: | KDJ |
| Classification Panel: | Gastroenterology/Urology |
5.3. Legally Marketed Predicate Device
The legally marketed predicate device is the Peritoneal Dialysis Drainage Set (K895991). This predicate has not been subject to a design-related recall.
5.4. Device Description
5.4.1. Device Identification
The Cycler Drain Bag Set (hereinafter referred to as "Drain Bag Set") is the subject of this 510(k).
5.4.2. Device Characteristics
The Drain Bag Set is a new, single-use device designed to collect patient effluent during the drain phase of an Automated Peritoneal Dialysis (APD) treatment. The Drain Bag Set is provided sterile and non-pyrogenic. The Drain Bag Set is sterilized using ethylene oxide (EO).
4
Image /page/4/Picture/1 description: The image shows the logo for Fresenius Medical Care. On the left is a blue symbol that looks like three chevrons stacked on top of each other, pointing downwards. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on top of "MEDICAL CARE".
5.4.3. Environment of Use
The Drain Bag Set is used in both healthcare and home environments.
Brief Written Description of the Device 5.4.4.
The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain Bag Set is used to collect effluent in bags rather than letting the effluent flow directly to a drain. The Drain Bag Set connects to the drain line of a cycler set to collect patient effluent by means of gravity and the pumping action of a Peritoneal Dialysis (PD) cycler. The Drain Bag Set connects to the drain line using a standard Luer lock connection. The Drain Bag Set consists of three (3) interconnected 7-liter drain bags, each with a sampling port and an occluding clamp. The tubing lines that connect each drain bag to the drain line have a snap-disconnect tubing segment. This tubing segment allows the user to disconnect individual bags by snapping the tubing apart.
5.4.5. Materials of Use
The component materials of the Drain Bag Set 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 Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (16 June 2016).
| Drain Bag Set Components | Material |
|---|---|
| Drain bag | |
| Tubing | Polyvinyl Chloride |
| (PVC) | |
| Male Luer lock adapter | |
| Vented cap for adapter | |
| Clamp | Polypropylene (PP) |
| Triple “Y” connector | |
| Snap-disconnect tubing segment | Polycarbonate (PC) |
| Sampling port | PC, Siliprene |
The Drain Bag Set components are composed of the following materials:
Key Performance Characteristics 5.4.6.
The Drain Bag Set is designed to be compatible with the Luer lock end of the Cycler Set drain line of Fresenius PD Cycler Sets. The drain bags have sampling ports that enable effluent sampling as needed. Each drain bag has a 7-liter nominal capacity and 8-liter maximum capacity.
5
Image /page/5/Picture/1 description: The image shows the logo for Fresenius Medical Care. On the left is a blue symbol that looks like three downward-pointing chevrons stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
5.5. Intended Use
The Drain Bag Set is intended for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis in a healthcare facility or at home. It is designed for use as an optional receptacle to collect patient effluent during an APD treatment with Fresenius PD Cyclers and Fresenius PD Cycler Sets.
Indications for Use 5.6.
The Cycler Drain Bag Set is indicated for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The Cycler Drain Bag Set is an optional receptacle that connects to the Luer-lock end of a Cycler Set drain line in order to collect patient effluent during PD treatments. This device is to be used only with Fresenius Medical Care (FMCNA) Cyclers and Cycler Sets.
5.7. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the Drain Bag Set are equivalent to the predicate Peritoneal Dialysis Drainage Set (K895991).
- Similar principle of operation
- Similar design characteristics
- Same sterilization method
- Same intended use
5.8. Performance Data
A summary of testing conducted to support the determination of substantial equivalence is as follows:
| Test
Conducted | Test Method Description | Acceptance
Criteria | Results/
Conclusion |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Drop Test | The drain bag was filled to capacity
with water and dropped from a height
of 0.25 m.
The test was performed in accordance
with ISO 15747:2010 Plastic
Containers for Intravenous Injections. | The drain bag shall
not leak (visual
inspection).
Acceptance criteria
from ISO 15747:2010
were applied. | Pass, results
within
acceptance
criteria |
| Test
Conducted | Test Method Description | Acceptance
Criteria | Results/
Conclusion |
| Internal Pressure
Test | The drain bags were exposed to an
internal pressure of 50 kPa between two
plane parallel plates maintaining the
pressure for 15 minutes.
The test was performed in accordance
with ISO 15747:2010 Plastic
Containers for Intravenous Injections. | The drain bag shall
not leak (visual
inspection)
Acceptance criteria
from ISO 15747:2010
were applied. | Pass, results
within
acceptance
criteria |
| Hanger Holes
Tensile Strength | The drain bags were filled to capacity
with water and were hung on a medical
hooking pole by attaching a load of 3.5
lbs (15 N) for 60 minutes.
The test was performed in accordance
with ISO 15747:2010 Plastic
Containers for Intravenous Injections. | The drain bag hanger
holes shall withstand
a tensile load of 15 N
for 60 minutes.
Acceptance criteria
from ISO 15747:2010
were applied. | Pass, results
within
acceptance
criteria |
| Film Roughness
Test | The drain bag film roughness was
measured in three different locations –
bottom, middle, and top of the bag–
with a roughness meter. | The drain bag's film
shall have a
roughness ≤ 0.75 µm
(Roughness Average) | Pass, results
within
acceptance
criteria |
| Tensile Strength
of Bonding
Engagements | A pull-off test was performed using the
applicable fixture for each bonded
engagement with the Instron machine. | All bonded
engagements between
plastic composites
shall require >10 lbf
to detach. | Pass, results
within
acceptance
criteria |
| Maintenance of
Sterility testing | The vented cap was validated as a
sterile barrier via the dust drum
microbial challenge test per
ANSI/AAMI/ISO 11607-1:2006/(R)
2010 - A1:2014 Packaging for
terminally sterilized medical devices –
Part 1: Requirements for materials,
sterile barrier systems, and packaging. | Acceptance criteria
from ISO 11607-
1:2006/(R) 2010 -
A1:2014 were
applied. | Pass, results
within
acceptance
criteria |
| Male Luer lock
connector
testing | The eight (8) Male Luer lock connector
tests were performed in accordance
with ISO 594-2:1998 Conical Fittings
with 6% (Luer) Taper for Syringes,
Needles and certain other Medical
Equipment. Part 2: Local Fittings
standard. | Acceptance criteria
from ISO 594-2:1998
were applied. | Pass, results
within
acceptance
criteria |
| Test
Conducted | Test Method Description | Acceptance
Criteria | Results/
Conclusion |
| Drain Bag Set
Capacity | The drain bags were filled to capacity
with water and it was observed if they
were able to contain such volume. | The Drain Bag Set
shall hold at least 24
L of water (volume ≥
24 L) | Pass, results
within
acceptance
criteria |
| Sampling Port
(i.e., injection
site) Leakage
Test | The sampling port was punctured using
a 23 gauge needle for 15 seconds and
was then exposed to an internal air
pressure of 20 kPa. The samples were
submerged in water for 15 seconds and
air leakages were inspected.
The test was performed in accordance
with ISO 15747:2010 Plastic
Containers for Intravenous Injections. | The sampling port
shall not leak after
being punctured with
a 23 gauge needle
one time for 15
seconds and
subjected to a
pressure of 20 kPa
under water for 15
seconds.
Acceptance criteria
from ISO 15747:2010
were applied. | Pass, results
within
acceptance
criteria |
| Snap Connector
Breakage Test | The snap connector was placed in a
poka-yoke mechanism and subjected to
a compression test with the Instron
machine starting from the injection
point (0°) and testing at 90°, 180°, and
270°. | The snap connector
shall have a break
point between 60 oz-
in and 120 oz-in | Pass, results
within
acceptance
criteria |
| Clamp Test | After activating the clamp on the
tubing, the tubing was submerged and
pressurized to 15 psi for 10 minutes.
Any leaks past the clamp were
observed.
This test method was adopted from ISO
8638:2010 Section 5.5.1.1
Cardiovascular
implants and extracorporeal systems –
Extracorporeal blood circuit for
hemodialyzers, hemodiafilters and
hemofilters | No leaks past the
clamp.
Acceptance criteria
from ISO 8638:2010
were applied. | Pass, results
within
acceptance
criteria |
| Test
Conducted | Test Method Description | Acceptance
Criteria | Results/
Conclusion |
| Vibratory (ship)
Testing | A simulated shipping distribution test
was performed using rotary motion.
The package was exposed to repetitive
shocks for a period of 60 minutes with
a frequency of 270 cycles per minute.
The test was performed in accordance
with ASTM D4169-14 Standard
Practice for Performance Testing of
Shipping Containers and Systems | No tubing kinks or
loose or damaged
components | Pass, results
within
acceptance
criteria |
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Image /page/6/Picture/1 description: The image contains the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
7
Image /page/7/Picture/1 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo, there are three blue chevron shapes stacked on top of each other, pointing downwards. To the right of the chevrons, the text "FRESENIUS MEDICAL CARE" is written in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
8
Image /page/8/Picture/1 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo is a blue symbol that consists of three downward-pointing chevrons stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in a bold, sans-serif font, also in blue. The words "FRESENIUS" and "MEDICAL CARE" are stacked on top of each other.
Results of the design verification tests met the design requirements for the proposed device and demonstrated that, like the predicate device, it is safe and effective for its intended use.
5.8.1. Biocompatibility Testing
No biocompatibility tests were performed.
Human Factors Validation Testing 5.8.2.
The Drain Bag Set was validated for its safe and effective use in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).
5.8.3. Software Verification and Validation Testing
Not applicable. The Drain Bag Set does not contain software.
Mechanical and Acoustic Testing 5.8.4.
No mechanical or acoustic tests were performed.
5.8.5. Animal Studies
No animal studies were performed.
5.8.6. Clinical Studies
No clinical studies were performed.
5.9. Conclusion
The intended use, design, principle of operation, and sterilization method of the Drain Bag Set is the same as that of the predicate device. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the Drain Bag Set device is safe and effective for its intended use.