The Compact Wearable Pump is intended to express and collect breastmilk from lactating women for the purpose of feeding collected breastmilk to a baby. The Compact Wearable Pump is intended for a single user.

Device Description

The Compact Wearable Pump is a battery-powered breast pump which consists of the following components: pump body, breast flange, flange insert, diaphragm, manifold disk, collection cup, charging cord, and carrying bag. The subject device is capable of single pumping (using both packaged pumps independently). It is provided non-sterile and can be re-used by a single user. It does not incorporate off-theshelf (OTS) software or wireless technology/mobile app software functionality. The subject device cannot be operated while plugged into AC power. The Compact Wearable Pump is designed to work in a user's bra. The main body includes a press-button user interface, pump body, and LED indicator lights. The user interface allows the user to switch from stimulation to expression mode and control the vacuum levels within those modes. Stimulation mode consists of 8 vacuum levels and fixed cycle speeds when used. Expression mode includes 8 vacuum levels with three different cycle speed configurations that vary duration between suction and let down for further customization by the user. The Compact Wearable Pump is capable of providing vacuum levels from 36-159 mmHg with cycling rates of 1.67-3.04 cycles per second in stimulation mode and vacuum levels from 78-280 mmHg with cycling rates from 0.53-1.99 cycles per second dependent on which expression mode is used. The Compact Wearable Pump is charged with a 5 V DC USB type C adaptor and powered by a 3.8 V, 1300mAh internal rechargeable lithium-ion battery. The breast pump expresses breast milk by creating a seal around the nipple using a flange and applying and releasing suction to the milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system. All other components (i.e., motor unit) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

AI/ML Overview

This document is a 510(k) summary for a breast pump, which is a medical device. As such, the acceptance criteria and study described are not typical of AI/ML-driven devices. There is no AI involved, no human readers, no ground truth established by experts for image interpretation, and no training set. The acceptance criteria relate to the physical and electrical performance of the breast pump, as well as its biocompatibility.

Here's an analysis based on the provided text, focusing on the available information:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Reported Device Performance (Summary)
Biocompatibility	- Cytotoxicity: Non-cytotoxic (according to ISO 10993-5:2009)
	- Sensitization: Non-sensitizing (according to ISO 10993-10:2010)
	- Irritation: Non-irritating (according to ISO 10993-10:2010)
Electrical Safety	- Compliant with ANSI/AAMI ES60601-1:2005/A2:2010
	- Compliant with IEC 62133-2:2017 (for Lithium systems)
	- Compliant with IEC 60601-1-11:2015 (for home healthcare environment)
Electromagnetic Compatibility (EMC)	Compliant with IEC 60601-1-2:2014
Software	Evaluated for moderate level of concern as per FDA guidance (2005)
Performance Testing	- Vacuum levels: Verified to meet mode/cycle specifications (36-159 mmHg stimulation, 78-280 mmHg expression)
	- Backflow protection: Verified that liquid does not backflow into tubing
	- Use life: Demonstrated that the device maintains specifications throughout its proposed use life
	- Battery performance: Demonstrated battery remains functional during its stated use-life
	- Battery status indicator: Demonstrated indicator remains functional during stated battery life
Milk-contacting components	Compliant with 21 CFR 174-179

Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of data for an AI/ML model. Instead, it refers to a device that undergoes physical and electrical testing.
- For biocompatibility, electrical safety, EMC, and performance testing, the "samples" would typically be a statistical number of physical devices or components of the device tested in a laboratory setting to ensure manufacturing consistency and adherence to specifications. The exact number of devices or components is not mentioned, but it would be determined by standard engineering and quality assurance practices for medical device manufacturing.
- There is no mention of geographical origin or retrospective/prospective nature of data as this is physical device testing, not data collection from a population.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the device is a physical breast pump, not an AI/ML diagnostic tool requiring expert consensus for ground truth. The "ground truth" here is adherence to technical standards and specifications, which is verified by engineering and laboratory testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human experts in diagnostic or prognostic studies, which is not the case here. Testing involves objective measurements and comparisons against predefined standards.
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:
- Not applicable. This device is not an AI-assisted diagnostic tool, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm or software-only product. It is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device is based on pre-defined technical specifications, international standards (ISO, IEC, ANSI/AAMI), and FDA regulations (e.g., 21 CFR). For example:
  - Biocompatibility: Ground truth is defined by the absence of cytotoxicity, irritation, and sensitization as determined by testing according to ISO 10993.
  - Electrical Safety & EMC: Ground truth is compliance with specified clauses and limits in IEC and ANSI/AAMI standards.
  - Performance (Vacuum levels, backflow protection, battery life): Ground truth is the device meeting its own design specifications (e.g., vacuum ranges, cycle rates, functional battery life) and demonstrating the intended mechanical and electrical functions without failure.
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no concept of a "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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June 30, 2023

Lansinoh Laboratories, Inc. Lindsay Ewers Director of Quality Assurance 99 Canal Center Plaza. Suite 550 Alexandria, VA 22314

Re: K230469

Trade/Device Name: Compact Wearable Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: May 31, 2023 Received: May 31, 2023

Dear Lindsay Ewers:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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; medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Monica D. Garcia -S

Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230469

Device Name Compact Wearable Pump

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - K230469

1. Submitter Information

Applicant:	Lansinoh Laboratories Inc.
Contact:	Lindsay Ewers
Phone:	(727) 542-3743
Email:	lewers@lansinoh.com
Address:	99 Canal Center Plaza, Suite 550Alexandria, VA 22314

2. Correspondent Information

Contact:	Lindsay Ewers
	Director of Quality Assurance
Firm:	Lansinoh Laboratories

3. Date prepared: June 29, 2023

4. Device Information

Device Name:	Compact Wearable Pump
Common Name:	Powered breast pump
Regulation Number:	21 CFR 884.5160
Regulation Name:	Powered Breast Pump
Product Code:	HGX (Pump, Breast, Powered)
Regulatory Class:	Class II

5. Predicate Device Information

Device Name:	Lansinoh Smartpump 3.0 Double Electric Breast Pump
510(k) Number:	K222726
Manufacturer:	Lansinoh Laboratories

The predicate device has not been subject to a design-related recall.

6. Device Description

The Compact Wearable Pump is designed to work in a user's bra. The main body includes a press-button user interface, pump body, and LED indicator lights. The user interface allows the user to switch from stimulation to expression mode and control the vacuum levels within those modes. Stimulation mode consists of 8 vacuum levels and fixed cycle speeds when used. Expression mode includes 8 vacuum levels with three different cycle speed configurations that vary duration between suction and let down for further customization by the user.

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The Compact Wearable Pump is capable of providing vacuum levels from 36-159 mmHg with cycling rates of 1.67-3.04 cycles per second in stimulation mode and vacuum levels from 78-280 mmHg with cycling rates from 0.53-1.99 cycles per second dependent on which expression mode is used. The Compact Wearable Pump is charged with a 5 V DC USB type C adaptor and powered by a 3.8 V, 1300mAh internal rechargeable lithium-ion battery.

The breast pump expresses breast milk by creating a seal around the nipple using a flange and applying and releasing suction to the milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.

All other components (i.e., motor unit) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

7. Indications for Use

8. Comparison of Intended Use and Technological Characteristics with the Predicate Device

The table below compares the intended use and technological characteristics of the subject and predicate device.

	Compact WearablePumpK230469Subject Device	Smartpump 3.0 DoubleElectric Breast PumpK222726Predicate Device	Comparison
Product Code	HGX	HGX	Same
Regulation Number	21 CFR 884.5160	21 CFR 884.5160	Same
Regulatory Class	Class II	Class II	Same
Patient Population	Lactating Women	Lactating Women	Same
Indications for Use	The Compact Wearable Pump isintended to express and collectbreastmilk from lactatingwomen for the purpose offeeding collected breastmilk to ababy. The Compact WearablePump is intended for a singleuser.	The Lansinoh Smartpump 3.0Double Electric Breast Pump isintended to express and collectthe breastmilk of a nursingwoman for the purpose offeeding collected breastmilk to ababy. The pump is intended for asingle user.	Same Intended Use
Pump Options	Single or Double	Single or Double	Same
Cycling controlmechanism	Microcontroller	Microcontroller	Same
Backflow Protection	Yes	Yes	Same
Mobile Application	No	No	Same
Indicators	Yes, LED indicators	Yes, LCD display and LEDindicators	Similar
Single User	Yes	Yes	Same

Table 1: Comparator Table for Subject and Predicate Devices

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Media separation(backflowprotection)	Yes	Yes	Same
Expression pattern	2-Phase	2-Phase	Same
Expression modes	3 styles	3 styles	Same
Suction levels(Stimulation)	36-159 mmHg	78-170 mmHg	Different. Differences in massagesuction levels do not raisedifferent questions of safety andeffectiveness
Suction levels(Expression)	78-280 mmHg	119-280 mmHg	Different. Differences inpumping suction levels do notraise different questions of safetyand effectiveness
Cycles per Second(stimulation)	1.67-3.04	1.61-2.56	Different. Differences inavailable cycle speed do not raisedifferent questions of safety andeffectiveness.
Cycles per Second(Expression)	Mode 1: 0.74-1.99Mode 2: 0.64-1.72Mode 3: 0.53-1.32	0.61-1.74	Different. Differences inavailable cycle speed do not raisedifferent questions of safety andeffectiveness.
Suction levels	8 vacuum levels	8 vacuum levels	Same
User Interface	On-Off switch, vacuumadjustment, Pump style switch	On-Off switch, vacuumadjustment, double/singlepumping, Pump style switch	Different. Differences inavailable suction levels do notraise different questions of safetyand effectiveness.
Adjustable SuctionLevels	Yes	Yes	Same
Design	Wearable Milk Collector andFlange	Tabletop Milk Collector andFlange	Different. Differences in overalldesign do not, on their own, raisedifferent questions of safety andeffectiveness.
Power Supply	3.8 V, 1300 mAh Lithium-IonPolymer battery	AC adapter or 7.4 V, 1500mAh Lithium-Ion Polymerbattery	Different. Differences inavailable power supply do notraise different questions of safetyand effectiveness as performanceis independently assessed foreach available powerconfiguration.

The indications for use of the subject and predicate device are similar, and they have the same intended use (i.e., for collection of breast milk from the breasts of lactating women).

The subject and predicate devices have similar technological features, including expression mode options, control mechanism, backflow protection, and device indicators. However, as shown in the table above, there are technological differences between the subject and predicate device, including different vacuum and cycle specifications, power supply, wear configurations, and vacuum levels. The different technological characteristics of the subject device, as compared to the predicate device, do not raise different questions of safety and effectiveness.

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9. Summary of Non-Clinical Performance Testing

Biocompatibility

Biocompatibility studies on the patient-contacting components of the subject device, including irritation, cytotoxicity, and sensitization testing were performed in accordance with the 2020 FDA guidance document Use of International Standard ISO 10993-1. "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process", as follows:

. Cytotoxicity (ISO 10993-5:2009)
Sensitization (ISO 10993-10:2010)
. Irritation (ISO 10993-10:2010)

The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.

Electrical Safety

Testing was conducted in accordance with ANSI/AAMI ES60601- 1:2005/A2:2010 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance), IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems, and IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

Electromagnetic Compatibility

Testing was conducted in accordance with IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests

Software

Software was evaluated for a moderate level of concern as recommended in the 2005 FDA guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

Performance Testing

Other performance testing was conducted to show that the device meets its design requirements and performs as intended. The performance tests include:

Vacuum level verification testing at each mode/cycle demonstrated that the devices . meet mode/cycle specifications.
. Backflow protection testing was conducted to verify liquid does not backflow into the tubing.
Use life testing was conducted to demonstrate that the device maintains its specifications throughout its proposed use life.
Battery performance testing was conducted to demonstrate that the battery remains functional . during its stated battery use-life.
Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life.

10. Conclusion

The results of the performance testing described above demonstrate that the Compact Wearable Pump is as safe and effective as the predicate device and supports a determination of substantial equivalence.

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).