(90 days)
Not Found
No
The device description mentions a microprocessor controlling the pumping cycle in automatic mode, but this is standard programmable logic, not AI/ML. There is no mention of learning, adaptation, or complex pattern recognition.
No.
Explanation: A therapeutic device is used to treat or cure a disease or condition. This device is a breast pump, which is used to express and collect breast milk, and does not treat or cure a medical condition.
No
This device is an electronic breast pump, intended to express and collect milk from the breasts of a lactating woman, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly lists hardware components such as a vacuum pump, 12V DC power supply, tubing, hand controller, and an electric motor controlled by a microprocessor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "express and collect milk from the breasts of a lactating woman." This is a physical process involving the body, not an in vitro (outside the body) test or analysis of biological samples.
- Device Description: The description details a mechanical pump that creates vacuum to extract milk. It does not mention any components or processes related to analyzing biological samples or diagnosing conditions.
- 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.)
- Detecting or measuring specific substances (analytes)
- Providing diagnostic information about a disease or condition
- Using reagents or test kits
The device is a medical device, specifically a breast pump, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The ISIS iQ DUO Twin Electronic Breast Pump is intended to express and collect milk from the breasts of a lactating woman.
Product codes
HGX
Device Description
The ISIS iQ DUO Twin Electronic Breast Pump is a safe and effective powered breast pump for expressing and collecting breast milk from the breasts of a lactating woman. The pumping can be performed on one breast or two breasts simultaneously, from independent diaphragms. The diaphragms within the pump are activated by a 12V DC electric motor controlled by a microprocessor. The device is comprised of a vacuum pump, 12V DC power supply, twin tubing with data cable, 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 powers the ISIS iQ DUO Breast Pump.
The ISIS iQ DUO Twin Electronic Breast Pump operates in two modes. In the manual mode, the user controls the frequency and level of vacuum by varying the strokelcycle 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breasts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The ISIS iQ DUO was tested on a total of 72 study subjects in the following studies: 48 study subjects (24 English-speaking and 24 Spanish-speaking) in the Human Factors/Labeling Study; and 24 study subjects in the Home Use Study.
In summary, the studies demonstrated that consumers can safely and effectively use the ISIS iQ under conditions of actual use; and that the User Guide, Quick Reference Guide, ISIS iQ DUO's physical design, and other human factors characteristics are appropriate for consumers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5160 Powered breast pump.
(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).
0
ISIS IQ DUO Twin Electronic Breast Pump
8 510(k) Summary
-
- I Submitter Name, Address, and Contact Information
| Submitter: | Avent America, Inc.
475 Supreme Drive
Bensenville, IL 60106 |
|-----------------|-------------------------------------------------------------------------------|
| Contact Person: | Ms. Miriam Sharif
Quality Engineer
(630) 694-7282
(866) 501-2982 Fax |
Summary Preparation Date 8.2
This 510(k) summary was prepared on May 27, 2005.
8.3 Name of Device
The trade name of the device is the ISIS iQ DUO Twin 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
8.5 Description of Device
The ISIS iQ DUO Twin Electronic Breast Pump is a safe and effective powered breast pump for expressing and collecting breast milk from the breasts of a lactating woman. The pumping can be performed on one breast or two breasts simultaneously, from independent diaphragms. The diaphragms within the pump are activated by a 12V DC electric motor controlled by a microprocessor. The device is comprised of a vacuum pump, 12V DC power supply, twin tubing with data cable, 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 powers the ISIS iQ DUO Breast Pump.
The ISIS iQ DUO Twin Electronic Breast Pump operates in two modes. In the manual mode, the user controls the frequency and level of vacuum by varying the strokelcycle 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.
1
Intended Use of the Device 8.6
The ISIS iQ DUO 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 DUO Breast Pump differs slightly from the predicate device. The ISIS iQ DUO provides total user control of the vacuum cycle and the ability to change between manual and automatic pumping. The predicate device is programmed to deliver two preprogrammed pumping cycles in an automatic mode only, and allows the user to have limited control of pump operation. The 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 ISIS iQ DUO also differs slightly in the technology employed to achieve let-down and milk flow. The predicate device employs "Natural Expression" technology described above to stimulate let-down and milk flow. The ISIS iQ DUO 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.
Both the ISIS iQ DUO, and the predicate operate with a sealed AC/DC transformer, but only the predicate device is capable of operating on battery power. The ISIS iQ DUO is identical to the predicate in all other aspects.
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 DUO meets all applicable electrical, mechanical, and environmental performance requirements given in the IEC 60601-1: 1998 + A1: 1991, A2: 1995, Corrigendum: 1994; ANSI/UL 60601:2003; EN-60601-1-1: 1990 + AI: 1993; AI 1: 1993, A12: 1993, A2: 1995, AI3: 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
The ISIS iQ DUO was tested on a total of 72 study subjects in the following studies: 48 study subjects (24 English-speaking and 24 Spanish-speaking) in the Human Factors/Labeling Study; and 24 study subjects in the Home Use Study.
In summary, the studies demonstrated that consumers can safely and effectively use the ISIS iQ under conditions of actual use; and that the User Guide, Quick Reference Guide, ISIS iQ DUO's physical design, and other human factors characteristics are appropriate for consumers.
2
8.10 Conclusion
Based upon the information presented in this dossier, it is concluded that the lSS iQ DUO is Based upon the information presented in this dossier, it is convalent to the predicate device.
3
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દ
f-ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20050
AUG 2 9 2005
Avent America, Inc. c/o Mr. Richard Morroney Vice President Clinivation, Inc. 1 Speen Street, Suite 160 FRAMINGHAM MA 01701
Re: K051413
R021419
Trade/Device Name: ISIS iQ DUO Twin Electronic Breast Pump Regulation Number: 21 CFR §884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: August 4, 2005 Received: August 5, 2005
Dear Mr. Morroney:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced We have revewed your becared by of(it) promotion (for the indications for use stated in above and have deceminated the ad needicate devices marketed in interstate commerce prior to the enclosure) to regary maneloce prodited Device Amendments, or to devices that have been May 26, 1970, the Chacultions of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordation with are proval application (PMA). You may, therefore, market the do not require approvation of a premiations of the Act. The general controls provisions of the Act device, subject to the general volta visting 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 If your device is classince (300 additional controls. Existing major regulations affecting your Apployal), It thay of subject to succraderal Regulations, Title 21, Parts 800 to 898. In addition, FDA device can be tound in the gode of soncerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination doce not mean that Please be advisou that I Dr 3 153dailed of a vith other requirements of the Act of any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Federal statues and regulations administered 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) (ZI CFR Part 801); good mandracting product radiation control product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
4
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 one 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 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
5
Indications for Use
KOS 1413 510(k) Number (if known):
Device Name: ISIS iQ DUO Twin Electronic Breast Pump
Indications For Use:
The ISIS iQ DUO Twin Electronic Breast Pump is intended to express and collect milk from the 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 Brogdon
(Division Sign-C etive Division of Repro Division
and Radiological De 510(k) Number
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