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.

AI/ML Overview

The provided text describes the ISIS iQ DUO Twin Electronic Breast Pump and its 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. This type of regulatory submission often relies on non-clinical performance data and limited clinical data to show safety and effectiveness, rather than extensive comparative effectiveness studies typical for novel medical devices or AI-powered diagnostics.

Given the nature of this submission, direct acceptance criteria in a quantitative, prescriptive manner (e.g., "sensitivity must be >90%") are not explicitly stated for individual device performance metrics in the way one might expect for a diagnostic or AI device. Instead, the "acceptance criteria" are implied by the demonstration of conformance to applicable safety and performance standards and the overall conclusion of substantial equivalence to a pre-existing legally marketed device (the Medela Pump in Style Advanced Breast Pump).

Here's an analysis based on the provided text, structured to address your specific points where information is available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied by Submission)	Reported Device Performance
Safety and Effectiveness: Consistent with predicate device.	Device is a "safe and effective powered breast pump". "The technological differences described above do not raise new concerns regarding the safety and effectiveness."
Electrical, Mechanical, and Environmental Standards Conformance:	Meets 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.
Biocompatibility/Material Safety (Milk/Tissue Contacting Parts):	"All milk-contacting and human tissue-contacting components are manufactured from materials that meet the appropriate regulations regarding food contact and/or biocompatibility."
Usability/Human Factors: Safe and effective use by consumers, appropriate User Guide.	"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."
Functional Equivalence: Performs the intended function of expressing and collecting milk.	"Intended to express and collect milk from the breasts of a lactating woman." The device operates in manual and automatic modes, controlling vacuum and frequency, similar to the predicate's purpose but with different control mechanisms.

2. Sample size used for the test set and the data provenance

Sample Size: 72 study subjects. This was split into:
- 48 study subjects (24 English-speaking and 24 Spanish-speaking) for the Human Factors/Labeling Study.
- 24 study subjects for the Home Use Study.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective, as they involve actively recruiting and observing subjects using the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the text. Given that the studies assess usability and safe/effective use for a breast pump, "ground truth" in the traditional sense of a diagnostic outcome is less applicable. The "ground truth" here is more about user experience, comprehension, and the device's ability to perform its function without adverse events, which would have been assessed by study personnel rather than clinical experts establishing a medical "ground truth."

4. Adjudication method for the test set

This information is not provided in the text. For human factors and home use studies, adjudication methods (like 2+1 review) are not typically used in the same way they would be for diagnostic accuracy studies. Assessment would likely be based on reported user feedback, observation, and analysis of safety events.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The ISIS iQ DUO Twin Electronic Breast Pump is a mechanical medical device, not an AI diagnostic, therefore, this type of study is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. The device is a mechanical breast pump. There is no "algorithm only" performance to evaluate in the context of an AI device. Its performance relies on its mechanical and electrical function, as well as user interaction. The "microprocessor" controls the pumping cycle based on user input, not autonomously interpreting medical data.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically defined for diagnostic devices (e.g., pathology for cancer detection) is not directly applicable here. For this breast pump, the "truth" or primary endpoints assessed in the studies relate to:

User Safety and Effectiveness: Whether users could safely and effectively operate the device and express milk. This would be observed and reported.
Usability/Human Factors: The clarity and appropriateness of the User Guide and the device's physical design. This would be assessed through user feedback and observation.
Conformance to Standards: Verification that the device meets defined electrical, mechanical, and biocompatibility standards.

8. The sample size for the training set

Not Applicable. This is a hardware medical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. As there is no AI model or training set, the concept of establishing ground truth for it is irrelevant in this context.

Summary

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ISIS IQ DUO Twin Electronic Breast Pump

8 510(k) Summary

1. I Submitter Name, Address, and Contact Information

Submitter:	Avent America, Inc.475 Supreme DriveBensenville, IL 60106
Contact Person:	Ms. Miriam SharifQuality 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

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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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.

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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.

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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.

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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

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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

Page 1 of ______

Regulation Number and Section

§ 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).