SPARMAX Aspirator VC-701 and TC-2000V are the portable AC powered suction pumps. Each one consists of an on/off switch, a pump unit, a non detachable flexible power cord, collection jar, relief valve, pressure gauge, pressure adjustment knob, bacteria filter, suction tubing.

AI/ML Overview

The provided text describes a 510(k) summary for the SPARMAX Aspirator VC-701 and TC-2000V. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics typically seen for AI/ML-based devices.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not available in this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Description of Criteria (as implied by the document)	Reported Device Performance
Intended Use	Device is used to remove fluids from the treated tracheotomy patient airway.	The device's intended use is identical to the predicate device.
Technological Characteristics	Similar in construction, function, safety, operating environmental conditions, and effectiveness to the predicate device.	"substantially equivalent to the predicate device" in these aspects.
Safety Features	Thermal switch for overheat/voltage lack protection.	SPARMAX includes a thermal switch that automatically shuts off the compressor when it becomes overheated or lacks voltage.
Electrical Safety & EMC	Compliance with relevant medical device electrical safety and electromagnetic compatibility standards.	Complies with UL 60601, EN 60601-1-2, UL 1450, and CAN/CSA-C22.2 No.68-92.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This submission focuses on demonstrating substantial equivalence through comparison of technical characteristics and performance standards compliance, not on a clinical study involving a test set of patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No ground truth for a test set was established in the context of this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study was not conducted as this is a traditional medical device (aspirator), not an AI/ML diagnostic tool requiring human reader performance evaluation.

6. If a Standalone Performance Study (algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a powered suction pump, not an algorithm. Its performance is evaluated through engineering and safety standards, not standalone algorithmic performance.

7. The Type of Ground Truth Used

Not applicable. For this type of device, "ground truth" typically refers to engineering specifications, performance standards, and comparison to the predicate device's established performance and safety profiles. There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for proving the performance of an aspirator in a 510(k) application.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware product, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

Summary

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K080005

APR 2 4 2008

510(k) Summary

[As required by section 807.92(c)]

1. Submitter: Ding Hwa Co., Ltd Rm.4B-02/03, Taipei World Trade Center, 4th Fl., No.5, Hsinyi Rd., Sec.5, Taipei, Taiwan 11011.
1. Manufacturer: Ding Hwa Co., Ltd No. 43, Hsinkung 1st Road, Peitou Industrial Park, Chang Hua Hsien, Taiwan.
1. Official Correspondent: Hui-chen Kai (Ms.)
1. Date of 510(k) Submittal: 04/12/2007
1. Device Trade Name: SPARMAX Aspirator VC-701 and TC-2000V
1. Common Name: Aspirator
1. Classification Name: Powered Suction Pump (FDA 21 CFR 878.4780 Class II)
1. Device Product Code: JCX
1. Predicate Device: DeVilbiss Suction Unit FDA (k)# K982304

10.Device Description:

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l 1.Intended Use:

The device is to be used to remove fluids from the treated tracheotomy patient airway.

12. Technological Characteristics:

Similar to the predicate device: In terms of intended use, construction, function, safety, operating environmental conditions. and effectiveness of the SPARMAX aspirator is substantially equivalent to the predicate device used for this application.

Different to the predicate device: The SPARMAX aspirator doesn't with the internal rechargeable portable battery and adopter. There are not significant effecting the safety and effectiveness to our aspirator.

The SPARMAX is with the thermal switch that automatically shuts-off the compressor when it becomes overheated or lack of voltage.

13.Performance Testing:
UL 60601, EN 60601-1-2, UL 1450, and CAN/CSA-C22.2 No.68-92. Refer to the attachment 3 and 4.

14.Conclusion:

In terms of intended use, construction, function, safety, operating environmental conditions, and effectiveness of the SPARMAX aspirator is substantially equivalent to the predicate device used for this application. The SPARMAX aspirator doesn't with the internal rechargeable portable battery and adopter. There are not significant effecting the safety and effectiveness to our application aspirator.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ding Hwa Co., Ltd. % Electronics Testing Center, Taiwan Hui-chen Kai No. 8, Lane 29, Wenming Road Guishan, Taoyuan 33383 Taiwan

APR 2 4 2008

Re: K080005

Trade/Device Name: SPARMAX Aspirator VC-701 and TC-2000V Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: JCX Dated: March 31, 2008 Received: April 14, 2008

Dear Hui-chen Kai:

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 such 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); good manufacturing practice requirements as set

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Page 2 -- Hui-chen Kai

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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.

Mark M. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO 80005

Indications for Use

510(k) Number (if known): Not known

Device Name: SPARMAX Aspirator VC-701 and TC-2000V

Indications For Use:

The device is to be used to remove fluids from the treated tracheotomy patient airway.

Prescription Use
(Part 21 CFR 801 Subpart D)
✓

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CJ Device Evaluation (ODE)

Expenden

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K080005

Page 1 of

Regulation Number and Section

§ 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.