(181 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical and material properties of a standard administration set, with no mention of AI or ML capabilities.
No.
The device description and intended use state that it is used to administer fluids, which is a supportive function rather than a direct therapeutic action that treats or cures a disease.
No
The device is described as an "Intravascular Administration Set" used to administer fluids, not to diagnose a condition. The performance studies focus on the materials and functional integrity for fluid administration, not diagnostic accuracy.
No
The device description clearly states it is an "Intravascular Administration Set," which is a physical medical device used for administering fluids. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to administer fluids into a patient's vascular system. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description reinforces the administration of fluids, which is an in-vivo action.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue) or providing information about a patient's health status based on such analysis. IVDs are designed to perform tests on these types of samples.
The device is an intravascular administration set, which is a medical device used for delivering substances directly into the bloodstream.
N/A
Intended Use / Indications for Use
The intended use of the BAIXINTM Intravascular Administration Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Indications for Use: Intravascular Administration Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
BAIXIN™ Intravascular Administration Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. This device is sterile and for single use only, so the following precautions shall be observed during use:
- (1) Don't use when visual damage on its packaging is detected or the
- protective cap is found not in position.
- (2) Only for single use, discard after use.
- (3) Use before expiration date.
- (4) It shall be used immediately after the individual package is opened.
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All materials used in the fabrication of the Anhui Kangda piston syringe and hypodermic needles were evaluated for:
| Test items | Requirements |
|---|---|
| Sterility | No evidence of growth of BI |
| Pyrogenicity | Free from pyrogenicity (Bacterial endotoxin test) |
| Haemolysis | The infusion set shall be free from haemolytic reactions |
| Toxicity | Free from toxicity |
| Reducing (oxidizable) matter | The total amount of potassium permanganate solution used [c(KMnO4)=0.002mol/l]shall not exceed 2.0ml; |
| Metal ions | The extract shall not contain in total more than 1µg/ml of cadmium, chromium, copper, lead and tin. Not more than 0.1µg/ml of cadmium, when determined by atomic absorption spectroscopy (AAS) or equivalent method. |
| Titration acidity or alkalinity | Not more than 1ml of either standard volumetric solution shall be required for the indicator to change to the colour grey |
| Residue on evaporation | The total amount of dry residue shall not exceed 5 mg. |
| UV absorption of extract solution | The extract solution S, shall not show absorption greater than 0.1. |
| EO residue | Less than 0.5mg/set |
| Particulate contamination | Contamination index1000ml |
| Injection port | There shall be no leakage of more than one falling drop of water. |
| Male conical fitting | In accordance with ISO594-1 or ISO594-2 |
| Protective cap | The protective caps shall maintain the sterility of the closure-piercing device, the male conical fitting and the interior of the infusion set. |
| Individual package | The infusion set and/or the air-inlet device shall be individually packed so that they remain sterile during storage. The unit container shall be sealed in a tamper-evident manner. |
| no flattened portions and kinks | The infusion set and/or the air-inlet devices shall be packed and sterilized in such a way that there are no flattened portions or kinks when they are ready for use |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
510(K) SUMMARY
Submitted by:
Anhui Kangda Medical Products Co., Ltd
88 Zhenxing Road,
Yangcun Town,
Tianchang City,
Anhui Province
P. R. China
Phone: +86 0550 7093893
+86 0550 7093800 Fax:
Preparation Date: Jun. 10. 2008
Contact Person/Prepared by:
Official Correspondent: bian wei giang SHANGHAI CARELIFE INTERNATIONAL TRADING CO., LTD. 1707 vingiao bldg 58 jinxin road jinqiao, pudong, shanghai, CHINA 201206 Phone: 86-21-50324423
US Agent: ROBERTJ. EDWARDS BOCA MEDICAL PRODUCTS, INC. 3550 nw 126th ave coral springs, FL 33065 Phone: 954 346 Fax: 954 346 Email: bob@bocapharmacal.com
510(K) Summary of Safety and Effectiveness for the:
Trade/Proprietary Name: BAIXIN™ Intravascular Administration Set
Common Name: INTRAVASCULAR ADMINISTRATION SET
Classification Name: set, administration, intravascular
Class: Il
JUN 1 1 2009
1
Procodes: FPA - set, administration, intravascular
Device Description:
BAIXIN™ Intravascular Administration Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. This device is sterile and for single use only, so the following precautions shall be observed during use:
- (1) Don't use when visual damage on its packaging is detected or the
- protective cap is found not in position.
- (2) Only for single use, discard after use.
- (3) Use before expiration date.
- (4) It shall be used immediately after the individual package is opened.
Intended Use:
The intended use of the BAIXINTM Intravascular Administration Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Statement to conform to ISO 8536-4-2007:
Anhui Kangda Medical Products Co., Ltd. has established that its family of syringes corm to the FDA recognized consensus standard, ISO 8536-4-2007, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed. Data supporting conformance with the standard is available from Anhui Kangda Medical Products Co., Ltd.
Summary of Testing:
All materials used in the fabrication of the Anhui Kangda piston syringe and hypodermic needles were evaluated for:
| Test items | Requirements | |
|---|---|---|
| Sterility | No evidence of growth of BI | |
| Pyrogenicity | Free from pyrogenicity (Bacterial endotoxin test) | |
| Haemolysis | The infusion set shall be free from haemolytic reactions | |
| Toxicity | Free from toxicity | |
| Reducing | ||
| (oxidizable) matter | The total amount of potassium permanganate solution used | |
| [c(KMnO4)=0.002mol/l]shall not exceed 2.0ml; | ||
| Metal ions | The extract shall not contain in total more than 1µg/ml of cadmium, chromium, copper, lead and tin. | |
| Not more than 0.1µg/ml of cadmium, when determined by atomic | ||
| absorption spectroscopy (AAS) or equivalent method. | ||
| Titration acidity or | ||
| alkalinity | Not more than 1ml of either | |
| standard volumetric solution | ||
| shall be required for the | ||
| indicator to change to the | ||
| colour grey | ||
| Residue on | ||
| evaporation | The total amount of dry | |
| residue shall not exceed 5 mg. | ||
| UV absorption of | ||
| extract solution | The extract solution S, shall | |
| not show absorption greater | ||
| than 0.1. | ||
| EO residue | Less than 0.5mg/set | |
| Particulate | ||
| contamination | Contamination index1000ml | |
| Injection port | There shall be no leakage of | |
| more than one falling drop of | ||
| water. | ||
| Male conical fitting | In accordance with ISO594-1 or ISO594-2 | |
| Protective cap | The protective caps shall | |
| maintain the sterility of the | ||
| closure-piercing device, the | ||
| male conical fitting and the | ||
| interior of the infusion set. | ||
| Individual package | The infusion set and/or the air-inlet device shall be individually packed | |
| so that they remain sterile during storage. The unit container shall be | ||
| sealed in a tamper-evident manner. | ||
| no flattened portions | ||
| and kinks | The infusion set and/or the air-inlet devices shall be packed and | |
| sterilized in such a way that there are no flattened portions or kinks | ||
| when they are ready for use |
2
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이 지원 기준
3
K08368
Conclusion:
The materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent and are safe and effective for their intended use. :
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter.
JUN 1 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Anhui Kangda Medical Products Company, Limited C/O Mr. Bian Wei Qiang Shanghai Carelife International Trading Company, Limited 1707 Yingiao Building 58 Jinxin Road, Jinqiao Pudong, Shanghai CHINA 201206
K083687 Re:
Trade/Device Name: BAIXINTM Intravascular Administration Set (BAIXINTM) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 3, 2009 Received: June 3, 2009
Dear Mr. Qiang:
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.
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.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Page 2- Mr. Oiang
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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 go to http://www.fda.gov/AboutFDA/Centers_Offices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anthony, is mistaken for
Susan Dunner, D.D.S., M.S.
Susan Runner, D.D.S., M. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): _ K083687
Device Name: BAIXIN™ Intravascular Administration Set (BAIXIN™)
Indications for Use: Intravascular Administration Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Over-The-Counter Use AND/OR Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
sta all
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083687
VIII