(204 days)
The CARE SU01A Suction aspirator is intended for professional use to remove infectious materials from wounds or fluids from a patient airway or respiratory support unit. The intended large population for this device is both adult and pediatric patients.
The SU01 A Suction aspirator is designed to provide general suction for use in hospitals or clinics. This Suction aspirator is a professional medical suctioning device that produces a maximum vacuum of 560 mmHg. It is used with a power supply allowing operation on AC voltage (120 VAC, 60 Hz). The device is equipped with 850ml collection bottle and has been designed for convenient and reliable and reliable usages. The vacuum pump of the SU01A transmits negative pressure throughout the tubing-system and the collection bottle to patient tubing that aspirates secretions or liquid form the body. The vacuum pump can be manually adjusted using the regulating value and the vacuum gage. The aspirated fluids are collected in the collection bottle that is isolated from the pump by a bacteria filter. It also has a mechanical overflow protection in the lid of the collection bottle to further prevent the fluids from being sucked into the pump.
Here's a breakdown of the acceptance criteria and study information for the K130001 device, the Foshan Care Medical Technology Co., Ltd. SU01A Suction aspirator, based on the provided text:
Important Note: This device is a traditional medical suction unit and not an AI/ML-powered device. Therefore, many sections related to AI performance, ground truth establishment, reader studies, and training sets are not applicable (N/A) for this submission. The analysis below reflects this.
1. Table of Acceptance Criteria and Reported Device Performance
This device's "acceptance criteria" are based on compliance with established medical device standards and equivalence to a predicate device. Performance is demonstrated through meeting these standards and showing comparable attributes to the predicate device.
| Acceptance Criteria / Attribute | Reported Device Performance (SU01A Suction Pump) | Predicate Device (SUA01 Suction Unit) Performance | Results |
|---|---|---|---|
| Compliant with IEC 60601-1 (Electrical safety) | Meet the requirements | Meet the requirements | Pass |
| Compliant with IEC 60601-1-2 (Electromagnetic compatibility) | Meet the requirements | Meet the requirements | Pass |
| Compliant with ISO 10079-1 (Medical suction equipment) | Meet the requirements | Meet the requirements | Pass |
| Controls easily identifiable by user | Meet the requirements | Meet the requirements | Pass |
| Collection Bottle volume reference markings | 850ml | 800ml | Pass |
| Collection Bottle withstands maximum pressure delivered by pump | Meet the requirements | Meet the requirements | Pass |
| Degree of collapse of tubing (less than 0.5) | Less than 0.5 | Less than 0.5 | Pass |
| Resistance to implosion for collection container | Meet the requirements | Meet the requirements | Pass |
| Flow rate of maximum pumping power | Meet the requirements | Meet the requirements | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: N/A. No specific "test set" of patient data or images was used as this is a hardware device submission focused on engineering standards and equivalence.
- Data Provenance: N/A. The evaluation is based on engineering testing protocols for compliance with international standards, rather than clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: N/A. No ground truth was established by experts for a test set in the context of clinical performance, as no such clinical studies were performed.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: N/A. No test set requiring expert adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done? No. This device is a physical suction aspirator; MRMC studies are not applicable.
- Effect Size: N/A.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study Done? N/A. This is a hardware device; algorithm-only performance is not relevant.
7. Type of Ground Truth Used
- Type of Ground Truth: N/A. For hardware devices like this, the "ground truth" for performance is typically defined by adherence to engineering specifications and international performance and safety standards, rather than clinical outcomes or expert consensus on clinical findings.
8. Sample Size for the Training Set
- Sample Size for Training Set: N/A. This is a hardware device and does not involve AI or algorithms that require training sets.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: N/A. No training set was used.
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JUL 2 5 2013
510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92
Submitter's Information 1.0
Establishment Registration Name:
Foshan Care Medical Technology Co., Ltd.
The 2F and 3F, G Building, No.1 Huabao Road Southern, Zhangcha, Chancheng District, Foshan, Guangdong, P. R. China 528000
Contact Person of applicant
Mr. Gang Wu - Chairman of directors
The 2F and 3F, G Building, No.1 Huabao Road Southern, Zhangcha, Chancheng District, Foshan, Guangdong, P. R. China 528000
TEL: +86-757-8802 3265 FAX: +86-757-8382 8966 Email: wugang@gse.cn
Contact Person of the Submission:
Ms. Kathy Guo
Foshan Care Medical Technology Co., Ltd.
The 2F and 3F, G Building, No.1 Huabao Road Southern, Zhangcha, Chancheng District, Foshan, Guangdong, P. R. China 528000
Email: medicaldevicefda@163.com
Device Information 2.0
| Type of 510(k) submission: | Traditional |
|---|---|
| Device Common Name: | Power Suction Unit |
| Trade Name: | Model SU01A Suction aspirator |
| Model: | SU01A |
| Classification name: | Apparatus, Suction, Ward Use, Portable, AC-Powered |
| Review Panel: | General & Plastic Surgery |
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| Product Code: | JCX |
|---|---|
| Regulation Class: | II |
| Regulation Number: | 878.4780 |
Predicate Device Information 3.0
| Sponsor: | EMG Technology Company, Ltd |
|---|---|
| Device: | Suction Unit, Model:SUA01 |
| 510(K) Number: | K042349 |
| Product Code: | JCX |
| Regulation Class: | II |
| RegulationNumber: | 878.4780 |
Device description 4.0
Powered suction pumps are described in FDA regulations, 21 CFR 878.4780, as:
"A powered suction pump is an AC-powered device intended to be used to remove infectious materials from wounds or fluids from 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. The FDA classified the device as a class II medical device".
The SU01 A Suction aspirator is designed to provide general suction for use in hospitals or clinics. This Suction aspirator is a professional medical suctioning device that produces a maximum vacuum of 560 mmHg. It is used with a power supply allowing operation on AC voltage (120 VAC, 60 Hz). The device is equipped with 850ml collection bottle and has been designed for convenient and reliable and reliable usages.
The vacuum pump of the SU01A transmits negative pressure throughout the tubing-system and the collection bottle to patient tubing that aspirates secretions or liquid form the body. The vacuum pump can be manually adjusted using the regulating value and the vacuum gage. The aspirated fluids are collected in the collection bottle that is isolated from the pump by a bacteria filter. It also has a mechanical overflow protection in the lid of the collection bottle to further prevent the fluids from being sucked into the pump.
Intended Use 5.0
The CARE SU01A Suction aspirator is intended for professional use to remove infectious materials from wounds or fluids from a patient airway or respiratory support unit. The intended large population for this device is both adult and pediatric patients.
Determination of Substantial Equivalence 6.0
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Summary of Technological Characteristics of the Device Compared to the Predicate Device
The CARE SU01 A Suction aspirator uses the same fundamental technology as the EMG SUA01 Suction Unit for most features. The indications for use of CARE SU01A Suction aspirator are the same as EMG SUA01 Suction Unit. CARE SU01A Suction aspirator is similar to the predicate devices in its indications for use and patient population. The user interface is also similar to the predicated devices. The main difference is in the volume of the collection bottle, which is increased but still sufficient for the expected daily volumes. The smaller size improves mobility.
Summary of Non-clinical Tests:
The CARE SU01 A Suction aspirator complies with voluntary standards for electrical safety, electromagnetic compatibility, and performance. The following quality assurance measures were applied to the development of the system:
- Electrical safety and electromagnetic compatibility testing per IEC 60601-1 ● and IEC 60601-1-2 standards, respectively
- Medical suction equipment Part 1 : Electrically powered suction equipment -● Safety requirements per ISO 10079-1
Summary of Clinical Tests:
No clinical studies were performed
CONCLUSION:
Foshan Care considers the SU01 A Suction aspirator to be as safe, as effective, and substantially equivalent to the predicate devices.
7.0 Effectiveness and Safety Considerations
Effectiveness:
The SU01 A Suction aspirator complies with ISO10079-1:1999.
Safety Considerations:
The applicant devices comply with IEC60601-1, Medical electrical equipment - Part l : General requirements for safety and IEC60601-1-2, Medical electrical equipment - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility - Requirements and tests.
The SU01A Suction aspirator is not a software controlled medical device, the software test according the software guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is not applicable.
The accessories which contact the patients directly are provided by the hospital but not the manufacture. All the accessories of the SU01 A Suction aspirator are not contact the patients, the biocompatibility test is not applicable.
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The clinical performance test is not applicable
Comparison to predicate device and conclusion 8.0
Comparison Analysis
The applicant device has same classification information, same indications and intended use, similar product design, similar technical specification and safety specification.
| SU01A Suction | SUA01 Suction | Results | |
|---|---|---|---|
| Attribute | Pump | Unit | |
| The pump shall be compliant | Meet the | Meet the | Pass |
| with IEC 60601-1 | requirements | requirements | |
| requirements | |||
| The pump shall be compliant | Meet the | Meet the | Pass |
| with IEC 60601-1-2 | requirements | requirements | |
| requirements | |||
| The pump shall be compliant | Meet the | Meet the | Pass |
| with ISO 10079-1 | requirements | requirements | |
| requirements | |||
| The pump controls shall be | Meet the | Meet the | Pass |
| easily identifiable by user | requirements | requirements | |
| The Collection Bottle should | 850ml | 800ml | Pass |
| have volume reference | |||
| markings | |||
| The Collection Bottle should | Meet the | Meet the | Pass |
| be able to withstand | requirements | requirements | |
| maximum pressure delivered | |||
| by the pump | |||
| The degree of collapse of the | Less than 0,5 | Less than 0,5 | Pass |
| tubing shall be less than 0,5 | |||
| throughout its entire length | |||
| when subjected to the | |||
| maximum vacuum stated | |||
| The resistance to implosion | Meet the | Meet the | Pass |
| for collection container | requirements | requirements | |
| The flow rate of maximum | Meet the | Meet the | Pass |
| pumping power | requirements | requirements |
Conclusion:
The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally marketed device. Therefore, the applicant device is determined as safe and effectiveness.
Compare with predicate device, they are very similar in design principle, intended use, functions, material and the adopting applicable standards. The differences between applicant device and predicate device do not raise any new questions of safety or effectiveness.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Foshan Care Medical Technology Co., Ltd. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K130001
Trade/Device Name: Care SU01A Suction Aspirator Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: JCX Dated: July 16, 2013 Received: July 17, 2013
Dear Mr. Job:
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.
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
July 25, 2013
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Page 2 - Mr. Mark Job
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/CDRHOffices/ucm 1 15809.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/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 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/ResourcesforYou/Industry/default.htm.
FOR
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
510(k) Number (if known): JS known): Suction aspirator Suction aspirator Device Name: SU01A Model:
Indications for Use:
The CARE SU01A Suction aspirator is intended for professional use to remove infectious The CARD DOGTT Caction abplaison a patient airway or respiratory support unit. The materials from Woulds of for this device is both adult and pediatric patients.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1 =
| DSD-DIVISION SIGN-OFF | |
|---|---|
| Division of Surgical Devices | |
| 510(k) Number: | K130001 |
| Joshua C. Nipper -S |
§ 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.