ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101

K052047 · Avent America, Inc. · HGX · Sep 22, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K052047
• Device Name: ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101
• Applicant: Avent America, Inc.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Sep 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Indications for Use

The ISIS iQ UNO Breast Pump is intended to express and collect milk from the breasts of a lactating woman.

Device Story

ISIS iQ UNO Handheld Electronic Breast Pump; powered breast pump for milk expression/collection. Components: vacuum pump, 6V DC motor, microprocessor, hand controller, manual pump parts, feeding bottles. Operation: manual mode (user controls vacuum frequency/level via handle lever); automatic mode (microprocessor-controlled cycle). User switches modes via control button. Power: AC/DC transformer or battery pack. Used by lactating women. Let-down stimulation via patented massage cushion and user-controlled frequency. Output: expressed milk. Benefits: provides user control over pumping cycles to facilitate milk flow.

Clinical Evidence

No clinical studies were performed. Bench testing only, including electrical, mechanical, and environmental performance testing per IEC 60601-1, ANSI/UL 60601, and FCC Part 15. Biocompatibility of milk-contacting materials confirmed.

Technological Characteristics

Powered breast pump; 6V DC motor; microprocessor-controlled. Materials meet food contact/biocompatibility regulations. Power: AC/DC transformer or battery. Standards: IEC 60601-1, ANSI/UL 60601, EN-60601-1-2, FCC Part 15. Features let-down massage cushion and soft-textured breast shield.

Indications for Use

Indicated for lactating women to express and collect breast milk.

Regulatory Classification

Identification

A powered breast pump in an electrically powered suction device used to express milk from the breast.

Predicate Devices

• Medela Pump In Style Advanced Breast Pump (K031614)
• Natural Comfort/Easy Comfort Battery/Electric Breast Pump (K032566)

Submission Summary (Full Text)

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K 65204

#### 510(k) Summary 8

### Submitter Name, Address, and Contact Information 8. I

| Submitter: | Avent America, Inc.<br>475 Supreme Drive<br>Bensenville, IL 60106 |
|-----------------|-------------------------------------------------------------------|
| Contact Person: | Ms. Miriam Sharif<br>Quality Engineer<br>[phone] |

#### Summary Preparation Date 8.2

This 510(k) summary was prepared on July 28, 2005.

[phone] Fax

#### 8.3 Name of Device

The trade name of the device is the ISIS iQ UNO Handheld Electronic Breast Pump. The common name is Powered Breast Pump. The classification name is Powered Breast Pump.

#### Name of Predicate Device 8.4

Medela Pump In Style Advanced Breast Pump, by Medela Inc., K031614; and Natural Comfort/Easy Comfort Battery/Electric Breast Pump, by The First Years, K032566.

#### Description of Device 8.5

The ISIS iQ UNO Handheld Electronic Breast Pump is a safe and effective powered breast pump used for expressing and collecting breast milk from the breasts of a lactating woman. The diaphragm within the pump is activated by a 6V DC electric motor controlled by a microprocessor. The device is comprised of a vacuum pump, 6V DC power supply, hand controller, Avent ISIS standard manual breast pump parts, and feeding bottles. The hand controller is designed to replicate the handle of the Avent standard manual ISIS Breast Pump, and is used to control the frequency and level of vacuum. A sealed AC/DC transformer or a battery pack powers the ISIS iQ UNO Breast Pump.

The ISIS iQ UNO Handheld Electronic Breast Pump operates in two modes. In the manual mode, the user controls the frequency and level of vacuum by varying the stroke/cycle of the control handle lever. After a comfortable manual pumping cycle has been established, the user engages the automatic pumping mode by depressing the control button on the hand controller. In the automatic mode, the pumping cycle is stored and controlled by the microprocessor. The user can switch between the automatic mode and manual mode at any time by repeatedly depressing the control button.

All milk-contacting and human tissue-contacting components are manufactured from materials that meet the appropriate regulations regarding food contact and/or biocompatibility.

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#### 8.6 Intended Use of the Device

The ISIS iQ UNO Breast Pump is intended to express and collect milk from the breasts of a lactating woman.

#### Summary of Technological Characteristics 8.7

The technology of the ISIS iQ UNO Breast Pump differs slightly from the Medela predicate device. The ISIS iQ UNO provides total user control of the vacuum cycle and the ability to change between manual and automatic pumping. The Medela predicate device is programmed to deliver two pre-programmed pumping cycles in an automatic mode only, and allows the user to have limited control of pump operation. The Medela predicate device is programmed to change from a high frequency pumping cycle (let-down mode) to a lower frequency pumping cycle (expression mode) two minutes after power has been applied ("Natural Expression" technology). The user can change the pump cycle only from the let-down mode to the expression mode at any time during the first two minutes of operation. The user can vary the vacuum level during either operational mode.

The technology of the ISIS iQ UNO Breast Pump differs slightly from the First Years predicate. The First Years predicate features a fully automatic auto-nursing cycle consisting of a onesecond suction and release. A dial knob on the pump handle controls the suction level.

The ISIS iQ UNO also differs slightly from the Medela predicate in the technology employed to achieve let-down and milk flow. The Medela predicate device employs "Natural Expression" technology described above to stimulate let-down and millk flow. The ISIS iQ UNO employs a patented let-down massage cushion designed to massage the area around the nipple in addition to allowing the user to control the frequency of the pumping cycle to stimulate let-down. The First Years predicate is similar to the ISIS iQ UNO regarding how let-down is stimulated. Both products employ a soft-textured breast shield.

The ISIS iQ UNO and both predicates operate with a sealed AC/DC transformer or with batteries.

The technological differences described above do not raise new concerns regarding the safety and effectiveness.

#### Summary of Non-clinical Performance Data 8.8

The ISIS iQ UNO meets all applicable electrical, mechanical, and environmental performance requirements given in the IEC 60601-1: 1998 + AI: 1991, A2: 1995, Corrigendum: 1994; ANSI/UL 60601:2003; EN-60601-1-1: 1990 + Al: 1993, Al 1: 1993, A12: 1993, A12: 1995, A13: 1996, Corrigendum: 1994; CAN/CSA C22.2 No. 601.1 issued: 1994/01/05 Rev: 1997/01/01; EN60601-1-2: 2001; and FCC Part 15 for a class B device. Additionally, all milk-contacting and human tissue-contacting components are manufactured from materials that meet the appropriate regulations regarding food contact and/or biocompatibility.

#### 8.9 Summary of Clinical Performance Data

No clinical studies were performed.

## 8.10 Conclusion

Based upon the information presented in this dossier, it is concluded that the ISIS iQ UNO is safe and effective for the intended use, and is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized eagle in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES". The eagle is depicted with three curved lines representing its body and wings, giving it a modern and abstract appearance. The logo is black and white and appears to be a scan or photocopy.

SEP 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Avent America, Inc. % Mr. Richard Morroney Vice President Clinivation, Inc. One Speen Street, Suite 160 FRAMINGHAM MA 01701 Re: K052047

Trade/Device Name: ISIS iQ UNO Handheld Electronic Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: July 29, 2005 Received: July 29, 2005

Dear Mr. Morroney:

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 (Premarket Approval), 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 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in you to organ and equivalence of your device of your device to a legally premarket nothleation: "The PDF mailing sification 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 If you desire specific acrree tor your are of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 807.77). Tou may ooually outer gallerial and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

K052047

Device Name: ISIS iQ UNO Handheld Electronic Breast Pump

Indications For Use:

The ISIS iQ UNO Handheld Electronic Breast Pump is intended to express and collect
s and collection in the times areas THE TOTO KE breasts of a lactating woman.

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)

Nancy C. Hodgson

(Division Sign-Off) () Division of Reproductive, and Radiological Dev 510(k) Number

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