(30 days)
Not Found
No
The description details a standard aspiration pump with mechanical components and controls. There is no mention of AI/ML terms, image processing, or data analysis that would suggest the use of such technology.
No.
The device is described as an aspiration pump intended for general suction use to remove bodily fluids and collect them, not to treat a specific medical condition or disease.
No
Explanation: The device is described as an "Aspiration Pump" intended for "general suction use in hospitals or clinics" to remove bodily fluids and collect them. Its accessories are for fluid collection and tubing. There is no mention of it being used to diagnose conditions or process data for diagnostic purposes.
No
The device description clearly outlines physical hardware components including a pump, housing, power button, vacuum regulator, analog pressure gauge, and canister shelf. It also includes physical accessories like a canister and tubing. There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general suction use in hospitals or clinics" to remove bodily fluids. This is a mechanical function for patient care, not for analyzing biological samples to diagnose or monitor a medical condition.
- Device Description: The description details a pump, canister, and tubing for collecting fluids. There is no mention of reagents, assays, or any components used for testing or analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers or other indicators of disease
The device is a powered suction pump, which falls under a different regulatory category than IVDs. The performance studies mentioned (IEC 60601-1-2, ISO 10079-1, IEC 60601-1, IEC 60529) are also standard for medical devices with mechanical functions, not IVDs.
N/A
Intended Use / Indications for Use
ZOOM Aspiration Pump: The ZOOM Aspiration Pump is intended for general suction use in hospitals or clinics.
ZOOM Canister: The ZOOM Canister is intended to collect aspirated fluids for disposal and prevent fluid ingress from damaging the ZOOM Aspiration Pump.
ZOOM Aspiration Tubing: The ZOOM Aspiration Tubing Set is intended to connect a suction catheter to the ZOOM Canister of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.
Product codes (comma separated list FDA assigned to the subject device)
JCX
Device Description
The ZOOM™ Aspiration Pump (ZOOM Pump) is an AC powered oil-less positive displacement pump capable of consistently delivering vacuum (0-29 inHg) for the removal of bodily fluids. The ZOOM Pump housing is fitted with a power (ON/OFF) button, one vacuum regulator, an analog pressure gauge and sliding canister shelf. The ZOOM Pump is provided non-sterile.
There are two accessories for the ZOOM Pump, the ZOOM™ Canister and ZOOM™ Aspiration Tubing. The ZOOM™ Canister is a non-sterile, single use 1000 mL canister which collects the removed bodily fluids. The ZOOM Canister is positioned in the sliding canister shelf and connected to the ZOOM Pump via the canister tubing and connectors. The ZOOM Aspiration Tubing is sterile, single use and connects to the blue connector on the canister lid.
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
hospitals or clinics.
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)
ZOOM™ Aspiration Pump was subjected to Electromagnetic Compatibility testing in accordance with IEC 60601-1-2 and performance bench testing in accordance with ISO 10079-1, IEC 60601-1 as well as IEC 60529. Testing for ZOOM™ Aspiration Pump were conducted by following the FDA's "Guidance Document for Powered Suction Pump 510(k)s" (Sept. 30, 1998). All the test results from the performance testing passed the acceptance criteria set forth by the respective standards.
Non-clinical performance testing of the ZOOM™ Aspiration Pump and its accessories:
Compliance with ANSI/AAMI ES60601-1 and CAN/CSA C22.2 NO. 60601-1: 100% Pass (YES)
Compliance with IEC 60601-1-2: 100% Pass (YES)
Compliance with ISO 10079-1: 100% Pass (YES)
Compliance with IEC 60529 for IP Code: The requirement for the IP 21 marking should be met. (YES)
ZOOM™ CANISTER (COMPLIANCE WITH ISO 10079-1): Design and Operational Requirements for ZOOM™ Canister and its Components: 100% Pass (YES)
ZOOM™ ASPIRATION TUBING: Operational Requirements for ZOOM™ Aspiration Tubing and its Components (Compliance with ISO 10079-1): 100% Pass (YES)
Compliance ISO 10993-1: Biocompatible (YES)
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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 21, 2019
Taiwan Biomaterial Co., Ltd. Monoj Kalita Deputy Manager, Regulatory Affairs 6F, No. 26-1, Sec.2, Shengyi Rd. Zhubei. 30261 Taiwan
Re: K190105
Trade/Device Name: ZOOM Aspiration Pump Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: JCX Dated: January 18, 2019 Received: January 22, 2019
Dear Monoj Kalita:
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. 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 located 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.
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 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by David David Krause -S Krause -S Krause -S
Date: 2019.02.21 14:10:37 -05'00
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190105
Device Name
ZOOM Aspiration Pump
Indications for Use (Describe)
ZOOM Aspiration Pump The ZOOM Aspiration Pump is intended for general suction use in hospitals or clinics.
ZOOM Canister
The ZOOM Canister is intended to collect aspirated fluids for disposal and prevent fluid ingress from damaging the ZOOM Aspiration Pump.
ZOOM Aspiration Tubing
The ZOOM Aspiration Tubing Set is intended to connect a suction catheter to the ZOOM Canister of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.
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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ZOOM™ Aspiration Pump
Special 510(k)
510(K) SUMMARY
1.1. APPLICANT INFORMATION
| Applicant Name | ---- Taiwan Biomaterial Co., Ltd. (TWBM) |
|---|---|
| Address | ---- 6F, No. 26-1, Sec.2, Shengyi Rd., Zhubei City, Hsinchu County |
| 30261, Taiwan. | |
| Telephone | ---- +886-3-6683088 |
| Fax | ---- +886-3-6683099 |
| Contact Person | ---- Monoj Mon Kalita, Ph.D. |
| Deputy Manager, Regulatory Affairs | |
| Phone: +886-3-6683088 ext. 309 | |
| Email: mon@twbm.com.tw | |
| Date Prepared | ---- February 5, 2019 |
SUBJECT DEVICE 1.2.
| Trade Name | ---- ZOOM™ Aspiration Pump |
|---|---|
| Common/Usual Name | ---- Powered Suction Pump |
| Device Class | ---- Class II |
| Regulation Number | ---- 21 CFR 878.4780 |
| Classification Name | ---- Apparatus, Suction, Ward Use, Portable, AC-Powered |
| Product Code | ---- JCX |
PREDICATE DEVICE NAME 1.3.
TWBM Pump (K180115)
1.4. INTENDED USE
ZOOM Aspiration Pump
The ZOOM Aspiration Pump is intended for general suction use in hospitals or clinics.
ZOOM Canister
The ZOOM Canister is intended to collect aspirated fluids for disposal and prevent fluid ingress from damaging the ZOOM Aspiration Pump.
ZOOM Aspiration Tubing
The ZOOM Aspiration Tubing Set is intended to connect a suction catheter to the ZOOM Canister of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.
4
Special 510(k)
ZOOM™ Aspiration Pump
1.5. DEVICE DESCRIPTION
The ZOOM™ Aspiration Pump (ZOOM Pump) is an AC powered oil-less positive displacement pump capable of consistently delivering vacuum (0-29 inHg) for the removal of bodily fluids. The ZOOM Pump housing is fitted with a power (ON/OFF) button, one vacuum regulator, an analog pressure gauge and sliding canister shelf. The ZOOM Pump is provided non-sterile.
There are two accessories for the ZOOM Pump, the ZOOM™ Canister and ZOOM™ Aspiration Tubing. The ZOOM™ Canister is a non-sterile, single use 1000 mL canister which collects the removed bodily fluids. The ZOOM Canister is positioned in the sliding canister shelf and connected to the ZOOM Pump via the canister tubing and connectors. The ZOOM Aspiration Tubing is sterile, single use and connects to the blue connector on the canister lid.
1.6.
TECHNOLOGICAL AND REGULATORY ATTRIBUTES COMPARISON
The technological and regulatory attributes of the subject device are compared with the predicate device as illustrated in the table below:
| Attributes | TWBM Pump
(Predicate Device) | ZOOM™ Aspiration Pump
(Subject Device) |
|------------------------|-------------------------------------------------------|-------------------------------------------|
| 510(k) Number | K180115 | K190105 |
| Classification Name | Apparatus, Suction, Ward Use,
Portable, AC-Powered | Same as predicate |
| Class | II | Same as predicate |
| Product Code | JCX | Same as predicate |
| Intended Use | General suction use in hospitals
or clinics | Same as predicate |
| Product Type | AC-Powered suction pump | Same as predicate |
| Manufacturer | TWBM | Same as predicate |
| Electrical requirement | 110-120Vac
60Hz | Same as predicate |
| Flow Rate | 0-0.8 SCFM (0-23 LPM) | Same as predicate |
| Vacuum Range | 0-29 inHg (0-737mmHg) | Same as predicate |
| Noise level |