MEDI-PUMP ASPIRATOR, MODEL 1615

K041199 · Thomas Industries · BTA · Jun 1, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041199
• Device Name: MEDI-PUMP ASPIRATOR, MODEL 1615
• Applicant: Thomas Industries
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Jun 1, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medi-Pump 1615 aspirator is intended to be used to remove bodily fluids from a patient's airway or respiratory system. The aspirator is a prescription device intended for use in the home by professional home healthcare providers and non-professional caregivers.

Device Story

Medi-Pump Model 1615 is a portable, AC-powered suction pump for home use. Device components include plastic enclosure, piston-style vacuum pump, vacuum regulator and gauge, 1000cc collection jar with overflow valve, in-line hydrophobic bacterial filter, and 6' PVC patient tube. Operated by professional home healthcare providers or non-professional caregivers to remove bodily fluids from patient airways. Output is vacuum suction; healthcare providers monitor fluid collection via jar and gauge to manage airway clearance. Benefits include portable, effective fluid removal for respiratory maintenance.

Clinical Evidence

Bench testing only. Device certified to UL 1431 (Standard for Safety: Personal Hygiene and Health Care Appliances). No clinical data provided.

Technological Characteristics

Portable AC-powered piston-style vacuum pump. Components: plastic enclosure, vacuum regulator/gauge, 1000cc plastic collection jar, overflow valve, in-line hydrophobic bacterial filter, 6' PVC tubing. Safety: UL 1431 certified. Features: single-use fuse overload protector, non-polarized power plug.

Indications for Use

Indicated for removal of bodily fluids from airway or respiratory system in home settings; for use by professional or non-professional caregivers.

Regulatory Classification

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.

Predicate Devices

• Medi-Pump Model 1210 Aspirator (K944399)

Submission Summary (Full Text)

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KO41199

JUN - 1 2004

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Attachment 5: 510(k) Summary

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Rietschie Thomas Sheboygan, Inc. 1419 Illinois Area of Bases Asemue

> Phone: [phone]
> Fax: [phone] www.rtpumps.com

| Applicant: | Thomas Industries<br>1419 Illinois Avenue<br>Sheboygan, WI 53082-0029<br>Telephone: [phone]<br>Fax: [phone] |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Daniel Pfister, Regulatory Affairs Specialist<br>Telephone: [phone]<br>Fax: [phone] |
| Date Prepared: | April 22, 2004 |
| Trade Name: | Medi-Pump Model 1615 Aspirator |
| Product Classification<br>and Code: | Powered Suction Pump<br>21 CFR §878.4780<br>Classification: II<br>Product Code: BTA - Pump, Portable, Aspiration |
| Predicate Device: | K944399 - Medi-Pump Model 1210 Aspirator |
| Device Description: | The Medi-Pump is a portable AC powered home use suction pump.<br>The device has been designed, tested and certified to UL 1431. The<br>primary device components include a plastic enclosure, a piston<br>style vacuum pump, a vacuum regulator and gauge, a 1000cc plastic<br>collection jar with overflow valve, an in-line hydrophobic bacterial<br>filter, and a 6' PVC patient tube. |
| Intended Use: | The Medi-Pump 1615 aspirator is intended to be used to remove<br>bodily fluids from a patient's airway or respiratory system. The<br>aspirator is intended for use in the home by professional home<br>healthcare providers and non-professional caregivers. |
| Summary of<br>Technological<br>Characteristics: | The model 1615 differs from the predicate model 1210 in the<br>following characteristics; the housing has been modified to provide<br>a more updated, appealing appearance, the device incorporates a<br>slightly different style vacuum pump which provides a slightly<br>higher vacuum, is equipped with a single use (fuse) overload<br>protector and has a non-polarized power plug. |
| | Both models have been tested and certified to UL 1431 - Standard<br>for Safety: Personal Hygiene and Health Care Appliances. |
| Conclusion: | In terms of construction, function, safety and effectiveness the<br>Model 1615 is substantially equivalent to the model 1210 which is<br>also a portable AC powered home use suction pump. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 1 2004

Mr. Daniel Pfister Regulatory Affairs Specialist Thomas Industries 1419 Illinois Avenue Sheboygan, Wisconsin 53082-0029

Re: K041199

Ko41177
Trade/Device Name: Medi-Pump Model 1615 Aspirator Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: April 22, 2004 Received: May 7, 2004

Dear Mr. Pfister:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection > re(t) premium is substantially equivalent (for the indications relerenced above and nave decembers and for use stated in the encrosure) to regary management date of the Medical Device American Frank Free began commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been reclassified in acceraapproval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, mercrore, maneer are act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (600 a0010) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations aff may be subject to back additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous neements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Drivice and that your device complies with other requirements of the Act that I DX has Intact a and regulations administered by other Federal agencies. You must of any I catal statutes und regulations sincluding, but not limited to: registration and listing (21 Comply will an the 11cg (21 CFR Part 801); good manufacturing practice requirements as set CI IT ratt 6077, adomig (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality byosins (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Mr. Daniel Pfister

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

ﮟ

510(k) Number (if known): K04 //99

Device Name: Medi-Pump Model 1615 Aspirator

Indications for Use:

The Medi-Pump 1615 aspirator is intended to be used to remove bodily fluids from a patient's airway or respiratory system. The aspirator is a prescription device intended for use in the home by professional home healthcare providers and non-professional caregivers.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K64/199