(129 days)
Not Found
No
The device description details a mechanical breast pump with user-controlled modes and vacuum levels. There is no mention of AI, ML, or any adaptive or learning functionality. The software evaluation is for a moderate level of concern, typical for devices with basic control software, not complex AI/ML.
Yes
The device is a breast pump, which is considered a therapeutic device as it performs a physiological function (expressing breastmilk) for a medical purpose.
No
The device description clearly states its purpose is to "express and collect breastmilk" and it achieves this by "creating a seal around the nipple... and applying and releasing suction." This is a functional description, not a diagnostic one. Diagnostic devices are used to identify the presence of a disease or condition.
No
The device description clearly outlines multiple hardware components (pump body, breast flange, collection cup, battery, etc.) and describes physical mechanisms of action (creating a seal, applying suction). While it mentions software evaluation, the device is fundamentally a physical breast pump with integrated software for control, not a software-only device.
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 breastmilk from lactating women for the purpose of feeding collected breastmilk to a baby." This is a physical process of collecting a biological sample (breastmilk) for direct use (feeding), not for diagnostic testing or analysis of the sample itself.
- Device Description: The description details a mechanical pump that creates suction to extract milk. It does not mention any components or functions related to analyzing the composition or characteristics of the breastmilk.
- Lack of Diagnostic Function: The device's operation is focused on the physical act of milk expression and collection. There is no indication of it performing any tests, measurements, or analysis on the breastmilk to diagnose a condition or provide information about a patient's health.
- No Mention of IVD-related activities: The document does not mention any activities typically associated with IVDs, such as analyzing samples, providing diagnostic results, or being used in a laboratory setting.
In summary, the Compact Wearable Pump is a medical device used for collecting a biological sample (breastmilk), but it does not perform any in vitro diagnostic testing on that sample.
N/A
Intended Use / Indications for Use
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.
Product codes
HGX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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 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.
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.
Key Metrics
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
Indications for Use
510(k) Number (if known) K230469
Device Name Compact Wearable Pump
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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 550 |
| Alexandria, 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 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.
4
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
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.
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 Wearable
Pump
K230469
Subject Device | Smartpump 3.0 Double
Electric Breast Pump
K222726
Predicate 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 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. | The Lansinoh Smartpump 3.0
Double Electric Breast Pump is
intended to express and collect
the breastmilk of a nursing
woman for the purpose of
feeding collected breastmilk to a
baby. The pump is intended for a
single user. | Same Intended Use |
| Pump Options | Single or Double | Single or Double | Same |
| Cycling control
mechanism | Microcontroller | Microcontroller | Same |
| Backflow Protection | Yes | Yes | Same |
| Mobile Application | No | No | Same |
| Indicators | Yes, LED indicators | Yes, LCD display and LED
indicators | Similar |
| Single User | Yes | Yes | Same |
Table 1: Comparator Table for Subject and Predicate Devices
5
| Media separation
(backflow
| protection) | 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 massage |
| suction levels do not raise | |||
| different questions of safety and | |||
| effectiveness | |||
| Suction levels | |||
| (Expression) | 78-280 mmHg | 119-280 mmHg | Different. Differences in |
| pumping suction levels do not | |||
| raise different questions of safety | |||
| and effectiveness | |||
| Cycles per Second | |||
| (stimulation) | 1.67-3.04 | 1.61-2.56 | Different. Differences in |
| available cycle speed do not raise | |||
| different questions of safety and | |||
| effectiveness. | |||
| Cycles per Second | |||
| (Expression) | Mode 1: 0.74-1.99 | ||
| Mode 2: 0.64-1.72 | |||
| Mode 3: 0.53-1.32 | 0.61-1.74 | Different. Differences in | |
| available cycle speed do not raise | |||
| different questions of safety and | |||
| effectiveness. | |||
| Suction levels | 8 vacuum levels | 8 vacuum levels | Same |
| User Interface | On-Off switch, vacuum | ||
| adjustment, Pump style switch | On-Off switch, vacuum | ||
| adjustment, double/single | |||
| pumping, Pump style switch | Different. Differences in | ||
| available suction levels do not | |||
| raise different questions of safety | |||
| and effectiveness. | |||
| Adjustable Suction | |||
| Levels | Yes | Yes | Same |
| Design | Wearable Milk Collector and | ||
| Flange | Tabletop Milk Collector and | ||
| Flange | Different. Differences in overall | ||
| design do not, on their own, raise | |||
| different questions of safety and | |||
| effectiveness. | |||
| Power Supply | 3.8 V, 1300 mAh Lithium-Ion | ||
| Polymer battery | AC adapter or 7.4 V, 1500 | ||
| mAh Lithium-Ion Polymer | |||
| battery | Different. Differences in | ||
| available power supply do not | |||
| raise different questions of safety | |||
| and effectiveness as performance | |||
| is independently assessed for | |||
| each available power | |||
| configuration. |
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.
6
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.