(60 days)
Not Found
No
The device description and performance studies focus on standard electrical and mechanical safety and performance, with no mention of AI/ML capabilities or related testing.
No.
The device is used to remove fluids and infectious materials, which is a supportive function rather than a direct therapeutic intervention that treats a disease or condition.
No
The device is described as a suction pump used to remove fluids, not to diagnose conditions. Its intended use is described as treatment/therapy (removing fluids), not diagnosis.
No
The device description explicitly lists hardware components such as a pump unit, collection bottle, relief valve, vacuum gage, bacteria filter, and suction tube, and the performance studies include electrical and EMC compliance tests according to hardware standards (IEC 60601-1, IEC 60601-1-2).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove fluids and infectious materials from the airway, respiratory support system, and wounds. This is a direct medical intervention on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical pump and collection system for suction, which aligns with its intended use for removing substances from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are designed to perform tests on samples (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical removal of substances from the body.
N/A
Intended Use / Indications for Use
The VEGA Medical Suction Equipment, model SU-01/SU-DC01 is a device used to remove fluids from airway or respiratory support system and infectious materials from wounds.
Product codes (comma separated list FDA assigned to the subject device)
JCX
Device Description
The VEGA Medical Suction Equipment, model SU-01/SU-DC01 is a portable AC powered suction pump. It consists of a pump unit, collection bottle, relief valve, vacuum gage, bacteria filter, and suction tube. The device is designed and manufactured to comply with IEC 60601-1. IEC 60601-1-2, and ISO 10079-1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway or respiratory support system and wounds
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)
Non-Clinical Tests Verification Activities Performed to Determine the Safety and Performance of SU-01/SU-DC01 are as the followings:
1> Performance Compliance Test according to ISO 10079-1 conducted by manufacturer
2> Electrical Compliance Test according to IEC 60601-1 by accredited laboratory.
3> EMC Compliance Test according to IEC 60601-1-2 by accredited laboratory.
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.
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
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.
0
510(K) SUMMARY
NOV 1 2 2010
This summary of 510(k) safety and effectiveness information is being prepared in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 at October 20, 2010.
The assigned 510(k) number is: K102626 .
- Submitter's Identifications: Establishment: DONGGUAN DALANG VIGOR ELECTRONICS MFY. Yang Wu District, Da Lang Town, Dong Guan City Guang Dong Prov., CHINA Registration Number: 9616843 Operations: Manufacturer
Owner/Operator: VEGA TECHNOLOGIES, INC. 11F-13, 100 Chang-Chun Rd., Taipei CHINA (Taiwan) 104. Owner/Operator Number: 9036509
Contact: Mr. Joseph Lu VEGA TECHNOLOGIES, INC. I1F-13. 100 Chang-Chun Rd. Taipei, CHINA (TAIWAN) 104 Phone: 886-2-2541-6996 Fax: 886-2-2521-3803
-
- Name of the Device: VEGA Medical Suction Equipment, model SU-01/SU-DC01.
-
- Information of the 510(k) Cleared Device (Predicate Device): DeVilbiss Suction Unit (K982304).
4. Device Description:
The VEGA Medical Suction Equipment, model SU-01/SU-DC01 is a portable AC powered suction pump. It consists of a pump unit, collection bottle, relief valve, vacuum gage, bacteria filter, and suction tube. The device is designed and manufactured to comply with IEC 60601-1. IEC 60601-1-2, and ISO 10079-1.
-
- Intended Use:
The VEGA Medical Suction Equipment, model SU-01/SU-DC01 is a device used to remove fluids from airway or respiratory support system and infectious materials from wounds.
- Intended Use:
1
VEGA TECHNOLOGIES, INC.
-
the operational specification(including vacuum range, flow rate, and collection bottle 1> capacity)
-
2> the operational power consumption.
-
3> the device outlook, dimensions, and weight.
-
mode of operation. 4>
-
7 . Discussion of Non-Clinical Tests Verification Activities Performed to Determine the Safety and_ Performance of SU-01/SU-DC01 are as the followings:
- 1> Performance Compliance Test according to ISO 10079-1 conducted by manufacturer
- 2> Electrical Compliance Test according to IEC 60601-1 by accredited laboratory.
- 3> EMC Compliance Test according to IEC 60601-1-2 by accredited laboratory.
-
- Discussion of Clinical Test Validation Activities Performed to Determine the Effectiveness of Device are as the followings: No particular Clinical Test was conducted for VEGA Medical Suction Equipment.
-
- Conclusions
The VEGA Medical Suction Equipment, model SU-01/SU-DC01, has the same intended use and technological characteristics as the cleared device of DeVilbiss Suction Unit (K982304). Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device.
In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.
2
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH &" is arranged vertically along the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Vega Technologies, Inc. % Mr. Joseph Lu 11F-13, 100 Chang-Chun Road Taipei, China (Taiwan) 104
NOV 1 2 2010
Re: K102626
Trade/Device Name: VEGA Medical Suction Equipment, Model SU-01/SU-DC01 Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: JCX Dated: November 02, 2010 Received: November 03, 2010
Dear Mr. Lu:
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, Or to 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 misbrandi, and adulteration. Please note: CDRH does not evaluate information related to contract lindility 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 an 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 af the Act or any Federal statutes and regulations administered by other Federal agencies. You must
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Page 2 - Mr. Joseph Lu
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/CentersOffices/CDRH/CDRHQffices/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/MedicalDevices/Safety/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
F-r Pithy
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number (if known): _ K102626
Device Name: VEGA Medical Suction Equipment, model SU-01/SU-DC01.
Indications For Use:
The VEGA Medical Suction Equipment, model SU-01/SU-DC01 is a device used to remove fluids from airway or respiratory support system and infectious materials from wounds.
Prescription Use OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Ogle for mxm
Division Sign (3)
Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K102626
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