(30 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the ZOOM™ Aspiration Pump, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ZOOM™ Aspiration Pump | ||
| Compliance with ANSI/AAMI ES60601-1 and CAN/CSA C22.2 NO. 60601-1 | 100% Pass | YES (implies 100% Pass) |
| Compliance with IEC 60601-1-2 | 100% Pass | YES (implies 100% Pass) |
| Compliance with ISO 10079-1 | 100% Pass | YES (implies 100% Pass) |
| Compliance with IEC 60529 for IP Code | The requirement for the IP 21 marking should be met. | YES (implies met the requirement for IP 21 marking) |
| ZOOM™ CANISTER (COMPLIANCE WITH ISO 10079-1) | ||
| Design and Operational Requirements for ZOOM™ Canister and its Components | 100% Pass | YES (implies 100% Pass) |
| ZOOM™ ASPIRATION TUBING | ||
| Operational Requirements for ZOOM™ Aspiration Tubing and its Components (Compliance with ISO 10079-1) | 100% Pass | YES (implies 100% Pass) |
| Compliance ISO 10993-1 | Biocompatible | YES (implies biocompatible) |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench testing for the device. For these types of tests (e.g., electrical safety, electromagnetic compatibility, performance standards), the concept of "sample size" in the same way as a clinical study (e.g., number of patients) isn't directly applicable. Instead, it refers to the number of units tested. However, the document does not specify the number of units of the ZOOM™ Aspiration Pump, ZOOM™ Canister, or ZOOM™ Aspiration Tubing that were tested for each criterion.
The data provenance is non-clinical bench testing conducted by the manufacturer, Taiwan Biomaterial Co., Ltd. (TWBM). There is no mention of country of origin for specific test data in terms of patient populations or retrospective/prospective studies, as these are not relevant for the described tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to the type of testing described. The listed acceptance criteria are based on established international and national standards (e.g., IEC, ISO, ANSI/AAMI). Compliance with these standards is determined by objective measurements and test procedures, not expert consensus on labels or diagnoses.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human interpretation of data (e.g., images) requires reconciliation among experts to establish a "ground truth" or reference standard. The testing here involves objective measurements against predefined engineering and performance standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers' performance changes with or without AI assistance, which is irrelevant for a hardware device like an aspiration pump.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
No, a standalone study in the context of an algorithm's performance was not done. "Standalone" refers to the performance of an AI algorithm intrinsically, without human interaction. The ZOOM™ Aspiration Pump is a physical medical device, not an AI algorithm. Its performance is measured directly against physical and functional standards.
7. The Type of Ground Truth Used:
The "ground truth" for the performance criteria is defined by the specifications and acceptable ranges established within the referenced national and international standards (e.g., IEC 60601-1-2, ISO 10079-1, IEC 60529, ANSI/AAMI ES60601-1, ISO 10993-1). Compliance is determined by objective measurements meeting these predefined limits.
8. The Sample Size for the Training Set:
This information is not applicable. "Training set" refers to data used to train machine learning models. The ZOOM™ Aspiration Pump is a physical device, and its development and testing do not involve machine learning training sets.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
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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
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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
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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 County30261, Taiwan. |
| Telephone | ---- +886-3-6683088 |
| Fax | ---- +886-3-6683099 |
| Contact Person | ---- Monoj Mon Kalita, Ph.D.Deputy Manager, Regulatory AffairsPhone: +886-3-6683088 ext. 309Email: 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.
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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 hospitalsor clinics | Same as predicate |
| Product Type | AC-Powered suction pump | Same as predicate |
| Manufacturer | TWBM | Same as predicate |
| Electrical requirement | 110-120Vac60Hz | 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 | <60dB | Same as predicate |
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ZOOM™ Aspiration Pump
Special 510(k)
| Attributes | TWBM Pump(Predicate Device) | ZOOM™ Aspiration Pump(Subject Device) |
|---|---|---|
| Dimensions | 12.2in×6.2in×11.3in(30.9cm×15.7cm×28.7cm) | 12.3in×7.2in×12.4in(31.3cm×18.3cm×31.5cm) |
| Weight | 14.8 lb (6.7 kg) | 15.2 lb (6.9 kg) |
| Duty Cycle | 45 min (20%) ON/ 3 hours (80%)OFF | 45 min (97.8%) ON/ 1 min (2.2%)OFF |
| Accessories | Canister• TWBM Canister 1000 mL,• Canister tubing,• Overflow protection valve,• Filter (Microbial, Hydrophobic),• Single Use Only,• Non-Sterile | ZOOM™ Canister• ZOOM™ Canister 1000 mL,• Canister tubing,• Overflow protection valve,• Filter (Microbial, Hydrophobic),• Single Use Only,• Non-Sterile |
| Aspiration TubingN/A | ZOOM™ Aspiration Tubing• Class II Exempt• EO Sterilized• Non-pyrogenic• Biocompatible• Single Use Only• ID: 0.110"• Length: 264.2cm• Flow clamp | |
| Operating Environment | Temp: 65°F | Same as predicate |
| Storage Environment | Temp: -20°F | Same as predicate |
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ZOOM™ Aspiration Pump
1.7. SUMMARY OF DEVICE TESTING
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.
1.8. SUMMARY OF NON-CLINICAL TESTING
The table below highlights the non-clinical performance testing of the ZOOM™ Aspiration Pump and its accessories, conducted for the determination of substantial equivalence with the predicate TWBM Pump and its accessory.
| Attributes | Acceptance Criteria | Result(YES/NO) |
|---|---|---|
| ZOOM™ ASPIRATION PUMP | ||
| Compliance with ANSI/AAMI ES60601-1 andCAN/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 IP21 marking should be met. | YES |
| ZOOM™ CANISTER (COMPLIANCE WITH ISO 10079-1) | ||
| Design and Operational Requirements forZOOM™ 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 |
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Special 510(k)
ZOOM™ Aspiration Pump
CONCLUSION
1.9.
Both the ZOOM™ Aspiration Pump as well as the predicate TWBM Pump are AC-Powered Suction Pumps with similar accessories for fluid containment. Additionally, the non-clinical bench testing results and the comparison of technological characteristics, intended use, the principle of operation and operating environment support the determination of ZOOM™ Aspiration Pump to be substantially equivalent to the predicate TWBM Pump. It can be concluded that the subject device performs as safe and effective as the predicate device.
§ 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.