(248 days)
Not Found
No
The device is a simple urine collection tube with a preservative, and the description and performance studies focus on its ability to maintain microbial viability during transport. There is no mention of any computational analysis or algorithms.
No
The device is described as a "Disposable Urine Collection Tube" intended for the "collection, transport and preservation of urine specimens" for laboratory testing, not for treatment or diagnosis of a disease or condition.
No
Explanation: The device is a urine collection tube intended for the collection, transport, and preservation of urine specimens for subsequent laboratory testing, not for performing the diagnostic analysis itself.
No
The device description clearly outlines physical components (tube, cap, plug, boric acid) made of specific materials (PET, butyl-rubber, PE). The performance studies focus on the viability of microorganisms within this physical collection system, not on software performance.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "collection, transport and preservation of urine specimens from the collection site to the testing laboratory, urine specimens are processed using standard clinical laboratory operating procedures for the cultivation of uropathogenic bacteria and yeasts." This clearly indicates that the device is intended to be used in vitro (outside the body) for diagnostic purposes (cultivation of bacteria and yeasts to identify potential infections).
- Device Description: The description details a system for handling biological specimens (urine) for subsequent laboratory testing.
- Performance Studies: The performance studies described (Microbial Recovery Studies, Fill Volume Impact Recovery Study) are focused on demonstrating the device's ability to maintain the integrity and viability of microorganisms in the urine specimen for accurate laboratory testing. This is a key characteristic of IVD devices used for specimen handling.
- Predicate Device: The mention of a predicate device (UriSwab™ - Urine Collection, Transport and Preservation System) which is also likely an IVD, further supports the classification of this device as an IVD.
The device is designed to prepare a biological specimen for subsequent diagnostic testing performed in a laboratory setting, which aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Disposable Urine Collection Tube is intended for the collection, transport and preservation of urine specimens from the collection site to the testing laboratory. In the laboratory, urine specimens are processed using clinical laboratory operating procedures for the cultivation of uropathogenic bacteria and yeasts.
Product codes
JSM, LIO
Device Description
The Disposable Urine Collection Tubes for the collection, transport and preservation system consist of a safety rubber plug, a plastic cap and boric acid as an additive inside the tube. The tube is made of Polyethylene terephthalate (PET) and the safety plug is made of butvl-rubber while the disposable cap is made of Polyethylene (PE). The disposable tube device sustains the viability of organisms during transport for up to 48 hrs. at 2-4°C and 22-25°C.There are two main tube types (round and conical bottom), and four configurations by volume of urine for the round bottom tubes (4 ml, 7 ml, 8 ml, 10 ml). The conical bottom tubes only have one configuration by volume (8 ml). Each volume is available in yellow and white caps.
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
It is intended to be used by health care professionals.
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)
Microbial Recovery Studies:
- Study Type: Microbial recovery (viability) studies.
- Sample Size: Sample panels were prepared from listed bacteria and yeast. Three lots of the Disposable Urine Collection Tubes with three samples per lot (N=9 for average CFU/ml recovered) were evaluated.
- Key Results: Inoculated sample tubes were stored at 2-4ºC and 22-25ºC for 24 and 48 hrs. After each storage time and temperature, samples were plated to grow colonies and counted to determine CFU/ml. The acceptance criterion was within 1 log10 of the initial microorganism count. The results show that all tested strains (Candida albicans, Escherichia coli, Enterococcus Faecalis, Pseudomonas aeruginosa, Proteus mirabilis, Staphylococcus saprophyticus, Citrobacter freundii, Candida glabrata, Enterobacter cloacae, Morganella morganii, Streptococcus agalactiae) had a change in Log10 (0 - 48 hrs) within the -0.17 to -0.55 range, meeting the acceptance criteria.
Fill Volume Impact Recovery Study:
- Study Type: Fill volume impact recovery study.
- Sample Size: Three production lots were tested in three replicates with urine samples spiked with E. coli, P. aeruginosa or P. mirabilis at 90% and 110% fill volumes (N=9 for average CFU/ml recovered).
- Key Results: The inoculated sample tubes were stored at 22-25°C for 0 and 48 hrs. The acceptance criterion was less than 1 log10 change when the fill volume is above or below the line. The results showed that for E. coli, P. aeruginosa, and P. mirabilis, the change in Log10 (0 - 48 hrs) for both 90% and 110% fill volumes ranged from -0.42 to -0.55, meeting the acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Microbial recovery was assessed by CFU/ml counts and change in Log10.
Predicate Device(s):
Reference Device(s):
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.2390 Transport culture medium.
(a)
Identification. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
November 17, 2022
Zhejiang Gongdong Medical Technology Co., Ltd. % Evan Hu Marketing & Technical Manager Shanghai Mind-link Consulting Co., Ltd. 1399 Jiangyue Road, Minhang Shanghai, Shanghai 201114 China
Re: K220739
Trade/Device Name: Disposable Urine Collection Tube Regulation Number: 21 CFR 866.2390 Regulation Name: Transport Culture Medium Regulatory Class: Class I, reserved Product Code: JSM, LIO Dated: March 7, 2022 Received: March 14, 2022
Dear Evan Hu:
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.
Please note that if you modify your IVD in the future to exceed any of the limitations to the exemption found in 21 CFR 866.9(c), your device will require a new 510(k) prior to marketing this device in the United States and will not be exempt from the premarket notification requirements so long as it exceeds the limitations to the exemption found in 21 CFR 866.9.
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.
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 medical devices and radiation-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.
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM) Branch Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220739
Device Name Disposable Urine Collection Tube
Indications for Use (Describe)
Disposable Urine Collection Tube is intended for the collection, transport and preservation of urine specimens from the collection site to the testing laboratory, urine specimens are processed using standard clinical laboratory operating procedures for the cultivation of uropathogenic bacteria and yeasts.
| 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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3
510(K) Summary
I. SUBMITTER:
Zhejiang Gongdong Medical Technology Co., Ltd.
No.10 Beiyuan Ave., Huangyan, Taizhou, Zhejiang, 318020, China
Contact Person: Handson Wei
Title: Sales Director
Tel: 86-0576-84115678
Email: handson(@chinagongdong.com
Submission Correspondent: Evan Hu
Email: Evan.hu@mind-link.net Tel:86-18616124827
Date Prepared: November 9, 2022
II. DEVICE
Name of Device: Disposable Urine Collection Tube Classification Name: Culture Media, Non-Propagating Transport FDA Panel: Microbiology Classification Number: 21 CFR 866.2390, Transport Culture Medium Regulatory Class: Class I Product Code: JSM, LIO
III. PREDICATE DEVICE
Primary predicate device: UriSwab™ - Urine Collection, Transport and Preservation System (K180052) Classification Name: Culture Media, Non-Propagating Transport FDA Panel: Microbiology Classification Number: 21 CFR 866.2390, Transport Culture Medium Regulatory Class: Class I Product Code: JSM, LIO
4
IV. DEVICE DESCRIPTION
The Disposable Urine Collection Tubes for the collection, transport and preservation system consist of a safety rubber plug, a plastic cap and boric acid as an additive inside the tube. The tube is made of Polyethylene terephthalate (PET) and the safety plug is made of butvl-rubber while the disposable cap is made of Polyethylene (PE). The disposable tube device sustains the viability of organisms during transport for up to 48 hrs. at 2-4°C and 22-25°C.There are two main tube types (round and conical bottom), and four configurations by volume of urine for the round bottom tubes (4 ml, 7 ml, 8 ml, 10 ml). The conical bottom tubes only have one configuration by volume (8 ml). Each volume is available in yellow and white caps. The different device configurations and information on the amount of preservative contained in each tube is provided in table 1.
Table 1. Description and Packaging configurations of Disposable Urine Collection Tube
| REF NO. | Draw volume (mL) | Tube size (Diameter × Length) in mm | Additive Boric acid in mg | Material | Type of tube | Cap colour |
|---|---|---|---|---|---|---|
| GD040UB | 4 | 13×75 | 40 | PET | Round bottom | yellow |
| GD040UBW | 4 | 13×75 | 40 | PET | Round bottom | white |
| GD070UB | 7 | 13×100 | 70 | PET | Round bottom | yellow |
| GD070UBW | 7 | 13×100 | 70 | PET | Round bottom | white |
| GD080UB | 8 | 16×100 | 80 | PET | Round bottom | yellow |
| GD080UBW | 8 | 16×100 | 80 | PET | Round bottom | white |
| GD100UB | 10 | 16×100 | 100 | PET | Round bottom | yellow |
| GD100UBW | 10 | 16×100 | 100 | PET | Round bottom | white |
| GD080UAC | 8 | 16×100 | 80 | PET | Conical bottom | yellow |
5
| GD080UACW | 8 | 16×100 | 80 | PET | Conical | white |
|---|---|---|---|---|---|---|
| bottom |
V. INDICATIONS FOR USE/INTENDED USE
Disposable Urine Collection Tube is intended for the collection, transport and preservation of urine specimens from the collection site to the testing laboratory. In the laboratory, urine specimens are processed using clinical laboratory operating procedures for the cultivation of uropathogenic bacteria and yeasts.
PRINCIPLE OF OPERATION VI.
The Disposable Urine Collection Tube system is used to safely collect and transport urine from collection sites to the testing laboratories. It is intended to be used by health care professionals. The vacuum in the collection tube allows autofill the urine sample through the puncture needle and the boric acid in the tubes prevents overgrowth of uropathogenic bacteria and yeasts.
COMPARISON WITH THE PREDICATE DEVICE VII.
The device, Disposable Urine Collection Tube is compared with the predicate device UriSwab - Urine Collection, Transport and Preservation System (K180052). The results are shown below in the comparison table:
| Device & Predicate
| Device(s): | Device: K220739 | Predicate: K180052 |
|---|---|---|
| Device Trade Name | Disposable Urine | |
| Collection Tube | UriSwab-Urine | |
| Collection, Transport | ||
| and Preservation | ||
| System | ||
| Device Product Code and | ||
| Classification | JSM, LIO, Class I | Same |
| General Device | ||
| Characteristic Similarities | ||
| Indications For Use | Disposable Urine | |
| Collection Tube is | ||
| intended for the | ||
| collection, transport, | ||
| and preservation of | Copan UriSwab™ - | |
| Urine Collection, | ||
| Transport and | ||
| Preservation System is | ||
| intended for the | ||
| urine specimens from | ||
| the collection site to the | ||
| testing laboratory. In the | ||
| laboratory, urine | ||
| specimens are | ||
| processed using | ||
| standard clinical | ||
| laboratory operating | ||
| procedures for the | ||
| cultivation of | ||
| uropathogenic bacteria | ||
| and yeasts. | collection, transport, | |
| and preservation of | ||
| urine specimens from | ||
| the collection site to the | ||
| testing laboratory. In the | ||
| laboratory, UriSwab™ | ||
| specimens are | ||
| processed using | ||
| standard clinical | ||
| laboratory operating | ||
| procedures for the | ||
| cultivation of | ||
| uropathogenic bacteria | ||
| and yeasts. | ||
| Specimen Stability | 2-4°C and 22-25°C; | |
| 48 hrs. | Same | |
| Device Storage Temperature | 22-25°C | Same |
| Sterilization | Radiation | Same |
| Sterile | Yes; 10-6 SAL | Same |
| General Device | ||
| Characteristic Differences | ||
| Tube material | Polyethylene | |
| Terephthalate (PET) | Plastic | |
| Tube type | Round and Conical | |
| bottom | Conical bottom | |
| Tube size | 13 mm × 75 mm; | |
| 13 mm x 100 mm; | ||
| 16 mm × 100 mm | 12 mm × 80 mm; | |
| 16 mm × 100 mm | ||
| Tube volume | 4 ml, 7 ml, 8 ml, 10 ml | 1.5 ml, 3.2 ml |
| Cap | Safety cap, yellow and | |
| white. | Screw cap, yellow |
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| Additive | Boric acid | Boric acid, Sodium
formate |
|-------------------|------------------------|------------------------------------|
| Collection device | PET tube with additive | Plastic tube, stick with
sponge |
| Tube filling | Predefined vacuum | Sponge applicator |
VIII. PERFORMANCE DATA
Analytical Performance
Microbial Recovery Studies:
Microbial recovery (viability) studies were conducted to support the claim of the Disposable Urine Collection Tube for the collection, transport and preservation of urine specimens from the collection site to the testing laboratory. Sample panels were prepared from the listed bacteria and yeast (below) that were commonly associated with urinary tract infections. Cultures from 1.5 × 10° (equivalent 0.5 McFarland standard) were diluted into the pooled human negative clinical urine matrix to give a final concentration of 1.5 x 102 CFU/ml. The appropriate volume of urine samples spiked with each organism was added to the Disposable Urine Collection Tubes. Three lots of the Disposable Urine Collection Tubes with three samples per lot were evaluated for the microbial recovery (viability) assay. The inoculated sample tubes were stored at 2-4ºC and 22-25ºC for 24, and 48 hrs. After each storage time and temperature, the samples were plated to grow colonies which were counted to determine CFU/ml for each time points. According to CLSI document M40-A2, the acceptance criteria for microbial recovery method was set to be within 1 log10 of the initial microorganism count. Results of recovery studies are presented in table 2.
| Strain tested | Storage
temperature | Average CFU/ml recovered
(N=9) at time points | Change in
Log10
(0 - 48 hrs) | | |
|----------------------------------------|------------------------|--------------------------------------------------|------------------------------------|--------|-------|
| | | 0 hr | 24 hrs | 48 hrs | |
| Candida albicans
(ATCC 24433) | 2-4°C | 140 | 107 | 85 | -0.22 |
| | 22-25°C | 140 | 74 | 69 | -0.31 |
| Escherichia coli
(ATCC 25922) | 2-4°C | 137 | 104 | 92 | -0.17 |
| | 22-25°C | 137 | 85 | 42 | -0.51 |
| Enterococcus Faecalis
(ATCC 29212) | 2-4°C | 145 | 102 | 91 | -0.20 |
| | 22-25°C | 145 | 80 | 54 | -0.43 |
| Pseudomonas aeruginosa
(ATCC 27853) | 2-4°C | 143 | 103 | 69 | -0.32 |
| | 22-25°C | 143 | 106 | 72 | -0.30 |
|--|
8
| Proteus mirabilis | 2-4°C | 140 | 111 | 72 | -0.29 |
|---|---|---|---|---|---|
| (ATCC 7002) | 22-25°C | 140 | 105 | 71 | -0.29 |
| Staphylococcus saprophyticus | 2-4°C | 139 | 109 | 69 | -0.30 |
| (ATCC 15305) | 22-25°C | 139 | 108 | 66 | -0.32 |
| Citrobacter freundii | 2-4°C | 140 | 104 | 73 | -0.28 |
| (ATCC 8090) | 22-25°C | 140 | 105 | 73 | -0.28 |
| Candida glabrata | 2-4°C | 137 | 111 | 77 | -0.25 |
| (ATCC MYA-2950) | 22-25°C | 137 | 102 | 77 | -0.25 |
| Enterobacter cloacae | 2-4°C | 138 | 107 | 67 | -0.31 |
| (ATCC 13047) | 22-25°C | 138 | 81 | 69 | -0.30 |
| Morganella morganii | 2-4°C | 139 | 111 | 69 | -0.30 |
| (ATCC 25829) | 22-25°C | 139 | 110 | 53 | -0.42 |
| Streptococcus agalactiae | 2-4°C | 143 | 112 | 69 | -0.32 |
| (ATCC 12386) | 22-25°C | 143 | 112 | 71 | -0.30 |
Fill Volume Impact Recovery Study:
A fill volume impact recovery study was performed to demonstrate that underfilling of Disposable Urine Collection Tube containing preservative does not negatively impact the viability of urine microorganism. Sample panels were prepared by listed microorganisms (below) diluted from 1.5 x 108 CFU/mL (equivalent to a 0.5 McFarland standard) into the pooled human negative clinical urine matrix to give a final concentration of 1.5 x 102 CFU/ml. Three production lots were tested in three replicates with each urine samples spiked with E. coli, P. aeruginosa or P. mirabilis at the sample fill volume of 90% and 110%. The inoculated sample tubes were stored at 22-25°C for 0 and 48 hrs. After each storage time, the samples were plated to grow colonies which were counted to determine CFU/ml for each time points. The acceptance criterium for the study is less than 1 log10 change when the fill volume is above or below the line. The results were shown in table 3.
| Table 3. Performance of Disposable Urine Collection Tube in fill volume impact | |||||
|---|---|---|---|---|---|
| recovery study. |
| Strain tested | Fill volume | Average CFU/ml recovered
(N=9) at time points | | Change in Log10
(0 - 48 hrs) |
|--------------------------------------|-------------|--------------------------------------------------|--------|---------------------------------|
| | | 0 hr | 48 hrs | |
| E. coli
(ATCC 25922) | 90% | 125 | 48 | -0.42 |
| E. coli
(ATCC 25922) | 110% | 127 | 46 | -0.44 |
| P. aeruginosa
(ATCC 27853) | 90% | 143 | 49 | -0.47 |
| P. aeruginosa
(ATCC 27853) | 110% | 142 | 50 | -0.45 |
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| P. mirabilis
| (ATCC 7002) | 90% | 140 | 40 | -0.54 |
|---|---|---|---|---|
| 110% | 139 | 39 | -0.55 |
IX. STERILIZATION
The Disposable Urine Collection Tubes were sterilized by electron beam radiation with an average dose of 20 kGy to achieve a sterility assurance level (SAL) of 10 ° with a dosimeter attached to monitor dosage through the sterilization process. Sterilization was validated following ISO 11137-1: 2006 and ISO 11137-2: 2013 Sterilization of Health Care Products Radiation guidelines. Sterility test was carried out according to ISO11137-2:2009 Medical Devices Radiation Sterilization-Microbiological Methods-Part 2. In this sterility test, 100 samples after irradiated at the verification dose were inoculated with 200 ml soybean casein liquid medium and incubated at 30±2℃ for 14 days. The results were observed with no growth.
X. SHELF LIFE
The shelf life for the Disposable Urine Collection Tube was determined to be 18 months from the date of manufacture when stored in well-ventilated clean room with the environment of relative humidity not more than 80% and at temperature 22 -25°C. The shelf life of the Disposable Urine Collection Tube was evaluated using real-time aging performance test at time points T = 0, 6, 12 and 18 months. At each time point, following performance test were conducted:
Appearance, Vacuum, Leak testing, Strength test, 50Kpa Pressure Test, PET tube's mechanical stress testing, Sterility test, Standards of boric acid content, Package integrity
Appearance test was carried out by inspecting visually for clear label, transparent PET tube and any sign of deformation or breakage. Vacuum test was performed by measuring volume drawn into the Disposable Urine Collection Tube between 90 to 110% of the nominal liquid capacity allowed. Physical and mechanical performance tests included leak test, strength test, and a 50 KPa pressure test. Mechanical stress test was conducted by checking the tubes could withstand centrifugation. The strength test, and urine collection volume capacity test were carried out as part of the evaluation. Sterility test and the standard of boric acid content (measuring the boric acid content in the tube) used were also assessed. The package integrity was evaluated by visually checking for any changes or damage to the package. Six lots of varying production were used for the studies and results showed that all samples passed the real time aging test for 18 months at 22-25°C.
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The results for shelf-life study support that the Disposable Urine Collection Tube is physically or visually stable for 18 months.