(104 days)
No
The device description and performance studies focus on the physical properties and safety of the tubing, with no mention of AI or ML.
No
The device is described as a connecting line for injection of contrast media, and its function is to deliver contrast media during a procedure, not to treat a disease or condition.
No
Explanation: The High Pressure Tubing is used to deliver contrast media during PTCA surgery. Its function is to connect an angiographic catheter and syringe, and it does not acquire, process, or interpret medical data for diagnostic purposes.
No
The device description clearly outlines physical components made of polycarbonate, silica gel, polyurethane, and nylon braided wire, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The High Pressure Tubing described is used during a medical procedure (PTCA surgery) to deliver contrast media into the patient's body. It's a tool used in a surgical intervention, not for analyzing samples taken from the body.
- Intended Use: The intended use clearly states it's for connecting components to deliver contrast media during surgery. This is an in-vivo application, not in-vitro.
The device is a medical device, but it falls under a different classification than IVDs.
N/A
Intended Use / Indications for Use
High Pressure Tubing is indicated for use in PTCA surgery to connect the angiographic catheter and the angiographic syringe to deliver contrast media.
Product codes
DXT
Device Description
High Pressure Tubing is designed as a connecting line for injection of contrast media during coronary angiographic procedures. The device has a pressure resistance of 1200psi (8.3MPa); It is divided into two series according to the luer connector combination. ETM series consists of tubing and rotating male luer connecters, and the ETF series consists of tubing and rotating male luer connecter; The rotating male luer connector and female luer connector are made of polycarbonate and silica gel; The tubing is made of polyurethane, and the middle of the tube wall also contains nylon braided wire, which does not contact with outside. The High is for single use only, non-pyrogenic, sterilized by EO gas and the sterilization process is validated. The High Pressure Tubing has 12 models and the differences for each model are listed in the following table 1.
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
The subject device, High Pressure Tubing, was subjected to the following applicable testing to assure reliable design and performance under the specified testing parameters:
Biocompatibility Testing:
Per ISO 10993-1: 2018 and FDA guidance, the following tests were performed to ensure the biocompatibility of the subject device.
- Cytotoxicity
- Sensitization
- Irritation or intracutaneous reactivity
- Material mediated pyrogenicity
- Acute systemic toxicity
- Hemocompatibility
Bench Testing:
Per ISO 8536-4: 2019, ISO 80369-7: 2021, ISO 80369-20: 2015, etc., the following tests were performed to ensure performance/functionality of the subject device.
- Visual
- Dimension
- Particulate Contamination
- Leakage
- Tensile Strength
- 6% Luer Connector
- EO Residual
- ECH Residual
- Sterility
- Endotoxin
- Pouch Visual
- Pouch Seal Peel Strength
- Pouch Integrity
Clinical Tests:
Clinical tests were not required to demonstrate performance of High Pressure Tubing. Product functionality has been adequately assessed by non-clinical tests.
Animal Tests:
Animal tests were not required to demonstrate performance of High Pressure Tubing. Product functionality has been adequately assessed by non-animal tests.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 28, 2024
Ningbo DIZEGENS Medical Science Co., Ltd. Zhang Wenwei Vice General Manager Floor 3&4, Building A4, No. 777, Binhai 4th Road Qianwan New Area. Ningo, Zhejiang 315336 China
Re: K232388
Trade/Device Name: High Pressure Tubing Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: DXT
Dear Zhang Wenwei:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 21, 2023. Specifically, FDA is updating this SE Letter due to a typographical error in the company name listed in the letter as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Shruti Mistry, Assistant Direction Devices at 301-796-6605 or Shruti.Mistry@fda.hhs.gov.
Sincerely,
Juliane C. Lessard -S
Juliane C. Lessard, Ph.D. Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and 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.
November 21, 2023
Ningbo DIZENGENS Medical Science Co., Ltd. Zhang Wenwei Vice General Manager Floor 3&4, Building A4, No. 777, Binhai 4th Road Qianwan New Area. Ningo, Zhejiang 315336 China
Re: K232388
Trade/Device Name: High Pressure Tubing Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: DXT Dated: October 27, 2023 Received: October 27, 2023
Dear Zhang Wenwei:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Juliane C. Lessard -S
Juliane C. Lessard Director, Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
3
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known) K232388
Device Name High Pressure Tubing
Indications for Use (Describe)
High Pressure Tubing is indicated for use in PTCA surgery to connect the angiographic catheter and the angiographic svringe to deliver contrast media.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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5
510(k) Summary
1. Submitter/510(k) Holder
Submission: Traditional 510(k) Premarket Notification Submitter: Ningbo DIZEGENS Medical Science Co., Ltd. Address: Floor 3&4, Building A4, No. 77, Binhai 4th Road, Qianwan New Area, Ningbo, Zhejiang Province, P.R. China. 315336 Contact Person: Zhang Wenwei, Vice General Manager Telephone: +86-574-82359758 Telefax: +86-574-82359059 Email: edwardzhang@dizegens.com Date prepared: Oct 27, 2023
2. Subject Device
Device Trade Name: High Pressure Tubing Device Common Name: High Pressure Tubing Regulatory Name: Angiographic injection and syringe Regulation Number: 21 CFR 870.1650 Product Code: DXT Regulatory Class: II Review Panel: Cardiovascular 510(k) Number: K232388
3. Predicate Device
The High Pressure Tubing is substantially equivalent to the following legally marketed predicate device.
| 510(k) Number | Trade Name | Manufacturer |
|---|---|---|
| K170014 | High Pressure Tubing | Shanghai Kindly Medical Instruments Co., Ltd. |
4. Device Description
High Pressure Tubing is designed as a connecting line for injection of contrast media during coronary angiographic procedures. The device has a pressure resistance of 1200psi (8.3MPa); It is divided into two series according to the luer connector combination. ETM series consists of tubing and rotating male luer connecters, and the ETF series consists of tubing and rotating male luer connecter; The rotating male luer connector and female luer connector are made of polycarbonate and silica gel; The tubing is made of polyurethane, and the middle of the tube wall also contains nylon braided wire, which does not contact with outside. The High is for single use only, non-pyrogenic, sterilized by EO gas and the sterilization process is validated. The High Pressure Tubing has 12 models and the differences for each model are listed in the following table 1.
6
| Table 1 Models of High Pressure Tubing | |||||
|---|---|---|---|---|---|
| No. | Model | Length(cm) | Luer Connector | ||
| Combination | Pressure | ||||
| Resistance(psi) | |||||
| 1 | ETF-025 | 25 | Rotating Male Luer | ||
| Connector + Female Luer | |||||
| Connector | 1200 | ||||
| 2 | ETF-050 | 50 | |||
| 3 | ETF | ||||
| Series | ETF-075 | 75 | |||
| 4 | ETF-100 | 100 | |||
| 5 | ETF-125 | 125 | |||
| 6 | ETF-150 | 150 | |||
| 7 | ETM-025 | 25 | Rotating Male Luer | ||
| Connector +Rotating Male | |||||
| Luer Connector | |||||
| 8 | ETM-050 | 50 | |||
| 9 | ETM | ||||
| Series | ETM-075 | 75 | |||
| 10 | ETM-100 | 100 | |||
| 11 | ETM-125 | 125 | |||
| 12 | ETM-150 | 150 |
Table 1 Models of High Pressure Tubing
5. Indications for Use
High Pressure Tubing is indicated for use in PTCA surgery to connect the angiographic catheter and the angiographic syringe to deliver contrast media.
6. Comparison of Technological Characteristics with the Predicate Device
The subject device, High Pressure Tubing, and the predicate device, High Pressure Tubing of Shanghai Kindly medical instruments Co., Ltd. have different intended use, indications for use, principle of operation but the differences do not raise additional concerns of safety and effectiveness. The subject device and predicate device have identical characteristics including components, technology and design, pressure rating, conical fitting, flexible, biocompatibility, sterilization, sterile, single use.
Difference in technology characteristics between the subject device, High Pressure Tubing, and predicate device, High Pressure Tubing, are provided in Table 2.
| Description | High Pressure Tubing
(Predicate Device) | High Pressure Tubing
(Subject Device) | Comparison to
predicate device |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| 510(k) Number | K170014 | K232388 | N/A |
| Regulation
Number | 21 CFR 870.1650 | 21 CFR 870.1650 | Same |
| Regulatory Name | Angiographic injection and syringe | Angiographic injection and syringe | Same |
| Product Code | DXT | DXT | Same |
| Regulatory Class | II | II | Same |
| Intended Use | The High Pressure Tubing is indicated for
use as a connecting line for injection of
contrast media or saline during coronary
angiographic procedures. | High Pressure Tubing is indicated for use
in PTCA surgery to connect the
angiographic catheter and the
angiographic syringe to deliver contrast
media. | Different1 |
| Indications for Use | The High Pressure Tubing is indicated for
use as a connecting line for injection of
contrast media or saline during coronary
angiographic procedures | High Pressure Tubing is indicated for use
in PTCA surgery to connect the
angiographic catheter and the
angiographic syringe to deliver contrast
media. | Different1 |
| Principle of
Operation | Manual connect the male luer or rotating
male luer of high pressure with other
catheter device. | 1. Check whether the package is
complete; Do not use if the unit
package has been damaged;
2. Open the package and check the
product., do not use if the product is
damaged or incomplete;
3. Connect the luer connector with the
corresponding device;
4. After the infusion of liquid, check
whether there is leakage at the
connecting position; If there is
leakage, it is necessary to check
whether the connection of the device
is loose and reconnect it firmly, or
replace it with a new product. | Different2 |
| Technology and
Design | Designed to multiple length and connector
types. PU tubing with polyamides liner for
1200psi | Designed to multiple length and
connector types. PU tubing with nylon
braided wire for 1200psi. | Different3 |
| Components | Tubing, female/male luer, rotating adapter | Tubing, Female Luer Connector, Rotating
Male Luer Connector | Same |
| Size | 30cm,60cm,90cm,120cm,150cm, | 25cm,50cm,75cm,100cm,125cm,150cm, | Different4 |
| Pressure Rating | 1200psi | 1200psi | Same |
| Conical Fitting | Comply with ISO 80369-7-2021 | Comply with ISO 80369-7: 2021 | Same |
| Flexible | Yes | Yes | Same |
| Biocompatibility | ISO 10993 series | ISO 10993 series | Same |
| Sterilization | EO sterilization | EO sterilization | Same |
| Sterile | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
Table 2 Technological Characteristics Comparison
T
7
Note': The subject device is intended to deliver contrast media in PTCA surgery same as predicate device, but not deliver saline which have significant decrease in risk compared to predicate device. This difference does not raise new or different questions of safety and effectiveness.
Note2: In Principle of Operation, the step 3 of subject device is identical with the operation of predicate device. In addition, more check steps have introduced to the operations of subject device, including step 1, 2 and 4, which
8
could decrease the risks in the operation. Therefore, this difference does not raise new or different questions of safety and effectiveness.
Noted: In Technology and Design, PU tubing with Nylon braided wire is the identical material with PU tubing with Polyamides liner that it just is the different description. This difference does not raise new or different questions of safety and effectiveness.
Note4: The sizes of predicate device are 30 to 150cm with 30cm intervals, and the sizes of subject device are 25 to 150cm with 25cm intervals. The minimum length of 25cm is suitable for potential clinical demand, and less length is meaning lower risk. The two devices have same longest configuration, 150cm, which is the most challenge size for characteristics. Therefore, this difference does not raise new or different questions of safety and effectiveness.
Conclusion: The differences between the subject and the predicate device do not raise additional questions of safety and effectiveness.
7. Performance Data
The subject device, High Pressure Tubing, was subjected to the following applicable testing to assure reliable design and performance under the specified testing parameters:
Biocompatibility Testing:
Per ISO 10993-1: 2018 and FDA guidance, the following tests were performed to ensure the biocompatibility of the subject device.
- . Cytotoxicity
- Sensitization
- . Irritation or intracutaneous reactivity
- Material mediated pyrogenicity ●
- Acute systemic toxicity ●
- . Hemocompatibility
Bench Testing:
Per ISO 8536-4: 2019, ISO 80369-7: 2021, ISO 80369-20: 2015, etc., the following tests were performed to ensure performance/functionality of the subject device.
- . Visual
- . Dimension
- Particulate Contamination
- Leakage ●
- Tensile Strength ●
- . 6% Luer Connector
- . EO Residual
- ECH Residual
- Sterility
- Endotoxin
- . Pouch Visual
- Pouch Seal Peel Strength .
9
. Pouch Integrity
Clinical Tests:
Clinical tests were not required to demonstrate performance of High Pressure Tubing. Product functionality has been adequately assessed by non-clinical tests.
Animal Tests:
Animal tests were not required to demonstrate performance of High Pressure Tubing. Product functionality has been adequately assessed by non-animal tests.
8. Conclusions
Based on the information presented in this 510(k) premarket notification, the subject device, High Pressure Tubing is considered substantially equivalent to the predicate device, High Pressure Tubing of Shanghai Kindly Medical Instruments Co., Ltd.