(254 days)
Not Found
No
The device description and performance studies focus on the physical components and standard testing of a gravity infusion set, with no mention of AI or ML capabilities.
No.
The device is used for delivering fluids, not for treating a disease or condition directly.
No
The device is described as being for "delivery of fluids from a container to a patient's vascular system," which is a therapeutic rather than a diagnostic function.
No
The device description explicitly lists multiple hardware components such as protective cap, spike, air filter, drip chamber, flexible tube, etc., and the performance studies focus on testing these physical components against various standards.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the delivery of fluids from a container to a patient's vascular system." This describes a device used for administering substances directly into the body, not for examining specimens from the body to obtain diagnostic information.
- Device Description: The description details components of an infusion set (spike, drip chamber, tubing, etc.), which are used for delivering fluids, not for performing in vitro tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any process related to obtaining diagnostic information from samples outside the body.
- Predicate Device: The predicate device is an "Intravascular Administration Set," which is consistent with a device used for delivering fluids into the vascular system, not an IVD.
IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for the delivery of fluids into the body.
N/A
Intended Use / Indications for Use
The device is indicated for the delivery of fluids from a container to a patient's vascular system.
Product codes
FPA
Device Description
The proposed devices are indicated for the gravity infusion of fluids from a container to a patient's vascular system through an IV catheter or infusion needle. . There are ten different models, each a different configuration comprised of various components which may include: protective cap, spike, air filter, drip chamber, precision filter, flexible tube, injection site, roller clamp, flow regulator, pinch clamp and luer lock connector. The devices are provided sterile and are single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Non clinical tests were conducted to determine that the proposed device met all design specifications to claim Substantially Equivalence (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 8536-4:2010 AMD 1 2013 Infusion equipment for medical use, Part 4: Infusion sets for single use, gravity feed
- ISO 8536-12:2007 AMD 1 2012 Infusion equipment for medical use- Part 12: Check valves.
- ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 1: General requirements
- ISO 594-2:1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock fittings
- ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals:
- ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials;
- USP38-NF33 Bacterial Endotoxins Test.
- ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
- ISO 10993-11:2006 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
- ASTM F 756-13 Standard practice for assessment of hemolytic properties of materials
- ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process
- USP 38-NF 33 Pyrogen Test
- Microbial Ingress Testing (Needleless Valve-Y Injection Site)
- ASTM F838-15-Standard Test for Determining Bacterial Retention of Membrane Filter (0.2 Micron Filter test)
- Flow Regulator Performance (Internal Specification)
- 1.2 Micron Filter Test (Internal Specification)
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
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 31, 2017
SHINVA ANDE Healthcare Apparatus Co., Ltd. c/o Ms. Diana Hong Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai 200120 CHINA
Re: K162601
Trade/Device Name: Infusion Set for Single Use Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: April 26, 2017 Received: April 28, 2017
Dear Ms. Diana Hong:
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Change Control Table, Change History
Change Control Table
| Version | Document Author | Document Approver | Date Approved |
|---|---|---|---|
| 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY |
Complete Change Control Table (all versions) retained in SWIFT Docs.
3
Indications for Use
510(k) Number (if known) K162601
Device Name Infusion Set for Single Use
Indications for Use (Describe)
The device is indicated for the delivery of fluids from a container to a patient's vascular system.
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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4
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K162601
- Date of Preparation: 05/25/2017 1.
-
- Sponsor Identification
SHINVA ANDE Healthcare Apparatus Co., Ltd.
No.77 Development Zone North Road, Zibo, Shandong, 255086 China
Contact Person: Xiaolei Tian Position: R&D Director Tel: +86-533-3917821 Fax: +86-533- 3918218 Email: tianxiaolei@andemed.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
-
- Identification of Proposed Device
Trade Name: Infusion Set for Single Use
- Identification of Proposed Device
Regulatory Information Regulation Name: Intravascular administration set Classification: II Product Code: FPA Regulation Number: 21CFR 880.5440 Review Panel: General Hospital
5
Indications for Use:
The device is indicated for the delivery of fluids from a container to a patient's vascular system.
Device Description
The proposed devices are indicated for the gravity infusion of fluids from a container to a patient's vascular system through an IV catheter or infusion needle. . There are ten different models, each a different configuration comprised of various components which may include: protective cap, spike, air filter, drip chamber, precision filter, flexible tube, injection site, roller clamp, flow regulator, pinch clamp and luer lock connector. The devices are provided sterile and are single use.
-
- Identification of Predicate Device
510(k) Number: K121803 Product Name: Intravascular Administration Set 510k Holder: Acta Medical
- Identification of Predicate Device
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to determine that the proposed device met all design specifications to claim Substantially Equivalence (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
ISO 8536-4:2010 AMD 1 2013 Infusion equipment for medical use, Part 4: Infusion sets for single use, gravity feed
-
ISO 8536-12:2007 AMD 1 2012 Infusion equipment for medical use- Part 12: Check valves.
-
ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 1: General requirements
-
ISO 594-2:1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock fittings
-
ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals:
-
ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials;
-
USP38-NF33 Bacterial Endotoxins Test.
-
ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
-
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
-
ISO 10993-11:2006 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
-
ASTM F 756-13 Standard practice for assessment of hemolytic properties of materials
-
A ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process
-
A USP 38-NF 33 Pyrogen Test
-
Microbial Ingress Testing (Needleless Valve-Y Injection Site)
6
-
ASTM F838-15-Standard Test for Determining Bacterial Retention of Membrane Filter (0.2 Micron Filter test)
-
Flow Regulator Performance (Internal Specification)
-
1.2 Micron Filter Test (Internal Specification)
- Clinical Test Conclusion 7.
No clinical study is included in this submission.
-
- Substantially Equivalent (SE) Comparison
| Table 1 Comparison of Technology Characteristics | ||
|---|---|---|
| Item | Proposed Device | Predicate Device | |
|---|---|---|---|
| Product Code | FPA | Same | |
| Regulation Number | 21 CFR 880.5440 | Same | |
| Indication for Use | The device is indicated for the | ||
| delivery of fluids from a container | |||
| to a patient's vascular system. | Acta Medical Intravascular administration set | ||
| intended use is to deliver sterile, infusion fluid | |||
| from a container to the patient with or without | |||
| flow control features. Acta Medical infusion | |||
| tubing may act as an extension of other infusion | |||
| tubing in delivering intravenous fluids from a | |||
| container to patient. | |||
| Configuration | Protector Cap of Spike | ||
| Spike | |||
| Air Vent | |||
| Air Filter | |||
| Drip Chamber | |||
| Fluid Filter | |||
| Flexible Tube | |||
| Check Valve | |||
| Needle Free Y Injection Site | |||
| Roller Clamp | |||
| Y Injection Site | |||
| Precision Filter | |||
| Pinch Clamp | |||
| Luer Lock Connector | |||
| Protector Cap of Luer Lock | |||
| Connector | Similar, except for the additional model | ||
| Minibore extension set | |||
| Sterile | EO sterilized | ||
| SAL 10-6 | Same | ||
| Single Use | Single Use | Same |
7
| Biocompatibility | ||
|---|---|---|
| Cytotoxicity | Conform with ISO 10993 requirements | Conform with ISO 10993 requirements |
| Intracutaneous Reactivity | ||
| Skin Sensitization | ||
| Acute Systemic Toxicity | ||
| Hemolysis Test | ||
| Pyrogen Test |
Device Comparison: The predicate device and subject device are similar in model configurations except the predicate device has an additional model, an extension set. The indications for use for the subject device and predicate device are similar except the predicate device has additional language to include the extension set and some models will come with or without a flow control feature. These minor differences in device design and indications for use do not raise different questions of safety or effectiveness.
9. Substantially Equivalent (SE) Conclusion
Based on the non clinical performance testing, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.