(257 days)
Not Found
No
The device description mentions a "microprocessor controlled DC electric motor" and a "user interface consists of a front panel keypad and LCD display" allowing the user to adjust settings. There is no mention of AI, ML, or any learning or adaptive capabilities based on data. The software is evaluated as "minor level of concern," which is typical for basic control systems, not complex AI/ML algorithms.
No
The device is described as an electric breast pump intended to express and collect breastmilk for feeding to a baby, rather than for treating or diagnosing a medical condition.
No
The device is a breast pump, intended to express and collect breastmilk for feeding. It does not mention analyzing or identifying any medical conditions or diseases, which would characterize a diagnostic device.
No
The device description explicitly details hardware components such as a diaphragm-type vacuum pump, DC electric motor, keypad, LCD display, and power options (batteries and AC adaptor). The 510(k) is primarily focused on updating the indications for use for a physical breast pump.
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 the breastmilk of a nursing woman for the purpose of feeding collected breastmilk to a baby." This is a physical process of extracting a bodily fluid for external use (feeding), not for diagnostic testing or analysis of the breastmilk itself.
- Device Description: The description focuses on the mechanical aspects of the pump (vacuum, motor, user interface) and its function in expressing milk. There is no mention of analyzing or testing the breastmilk.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue, or in this case, potentially breastmilk) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
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 Lansinoh® Signature Pro™ 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 multiple users, and single users.
The Lansinoh® Smartpump™ Double Electric Breast Pump is intended to express and collect the breasmilk of a nursing woman for the purpose of feeding collected breastmilk to a baby. The pump is intended for multiple users, and single users.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Lansinoh Powered Breast Pumps are intended to express the breast milk of a nursing woman. The pumping can be performed on one breast or on both breasts at the same time. The pump can be powered by 6 AA batteries or by an AC adaptor that is provided with the pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microprocessor controlled DC electric motor. The user interface consists of a front panel keypad and LCD display. The user is able to adjust cycle mode and vacuum level based on personal comfort and preference.
The purpose of this 510(k) is to update the indications for use statement to include use by multiple users. The labeling has been revised to clarify that the collection kits are for single users only and are not to be shared with other users.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
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)
Bench Performance
Suction Curves: Devices were evaluated for suction performance at each of the available settings. The suction curves for each cycle mode and suction level demonstrated that the device meets its specifications and performs within the specified working ranges of pressure and cycle speed for each mode/level.
Battery Life Testing: Battery life was measured with the pumps at the highest level ((Expression Mode 3, Level 8). The "fail time" was defined as the number of minutes the pump could run at this level before dropping below specifications. Testing supports that the battery life of the device, as noted in the labeling, is approximately 90 minutes.
Sterilization, Cleaning and Shelf Life
Sterilization and Cleaning: The device is reusable, provided non-sterile, and is not sterile when used. Cleaning instructions are provided in the labeling.
Shelf-life: Shelf-life is not applicable due to the low likelihood of time-dependent product degradation. However, in accordance with IEC 60601-1:2005/(R)2012 the subject devices expected use-life is 500 hours. In testing, the devices were demonstrated to operate within specifications for up to 500 hours of continuous operation at the maximum setting (Expression mode 3, Level 8).
Backflow Test: The Lansinoh pumps are designed as a closed milk collection system. The diaphragm provides a physical barrier, preventing breastmilk from flowing into the tubing or pump body. The purpose of the backflow test is to demonstrate that the design prevents backflow into the tubing and pump. Devices were tested at maximum pressure/cycle settings (Expression Mode 3, Level 8) at various orientations to simulate worst-case conditions. The testing demonstrated that no milk was present in test devices' tubing during and following the test; therefore the diaphragm was demonstrated to prevent back flow of milk into the tubing and pump.
Biocompatibility: There have been no changes to the patient contacting materials used in the subject device since its previous clearance in K122474. Therefore, biocompatibility data from K122474 can be leveraged to support the biocompatibility of the subject devices. The milk contacting components are those components that are provided in the pump kit. All materials in contact with milk have been tested to meet FDA's Food Additive criteria (21 CFR 175-179).
Electrical Safety and EMC: The device was tested for electrical safety in accordance with (ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012) and EMC in accordance with (IEC 60601-1-2:2007). The device was demonstrated to meet applicable test limits for electrical safety and EMC per the cited standards.
Software and Cybersecurity: The software was evaluated as a minor level of concern per FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005. Documentation consistent with a minor level of concern demonstrated the software functions as intended. Cybersecurity for the subject devices was evaluated through a risk-based approach. Appropriate mitigations were implemented based upon the level of risk of the devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 12, 2019
Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd. Sti. % Lindsay Ewers Director of Quality Assurance Lansinoh Laboratories 333 N. Fairfax Street, Suite 400 Alexandria, VA 22314
Re: K182749
Trade/Device Name: Lansinoh® Signature Pro™ Double Electric Breast Pump (DEBP 2.1) Lansinoh® Smartpump™ Double Electric Breast Pump (DEPB 2.2) Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: May 16, 2019 Received: May 17, 2019
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.
1
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); 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 medical devices and radiation-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.
Sharon M. Andrews Assistant Division 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) K182749
Device Name
Lansinoh® Signature Pro™ Double Electric Breast Pump (DEBP 2.1) Lansinoh® Smartpump™ Double Electric Breast Pump (DEPB 2.2)
Indications for Use (Describe)
The Lansinoh® Signature Pro™ 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 multiple users, and single users.
The Lansinoh® Smartpump™M Double Electric Breast Pump is intended to express and collect the breasmilk of a nursing woman for the purpose of feeding collected breastmilk to a baby. The pump is intended for multiple users, and single users.
| Type of Use (Select one or both, as applicable) |
|---|
| Exempted New Part 613 Subchapter S Project |
| One-Time Community SEP New Subchapter S Project |
| | 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
| Device Common Name: | Powered Breast Pump |
|---|---|
| Device Trade Name: | Lansinoh® Signature Pro™ Double Electric Breast Pump |
| (DEBP 2.1) and Lansinoh® Smartpump™ Double Electric | |
| Breast Pump (DEBP 2.2) | |
| Submitter: | Lansinoh Laboratories Saglık Gerecleri San. Tic. Ltd. Sti. |
| 10006 sokak, No:64 | |
| A.O.S.B. Cigli - Izmir 35620 | |
| TURKEY | |
| Tel: 0090 232 328 05 06 | |
| Fax: 0090 232 328 05 58 | |
| www.lansinoh.com.tr | |
| Company Contact: | Barbaros Karadağ |
| General Manager | |
| Lansinoh Laboratories Saglık Gerecleri San. Tic. Ltd. Sti. | |
| Tel: +90 232 328 05 06 | |
| barbaroskaradag@lansinoh.com.tr | |
| Date Prepared: | June 11, 2019 |
| Classification Regulation: | 21 CFR 884.5160, Class II, Powered Breast Pump |
| Panel: | Obstetrics/Gynecology |
| Product Code: | HGX - Powered Breast Pump |
Indication for Use:
The Lansinoh® Signature Pro™ 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 multiple users, and single users.
The Lansinoh® Smartpump™ 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 multiple users, and single users.
Device Description:
The Lansinoh Powered Breast Pumps are intended to express the breast milk of a nursing woman. The pumping can be performed on one breast or on both breasts at the same time. The pump can be powered by 6 AA batteries or by an AC adaptor that is provided with the pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microprocessor controlled DC electric motor. The user interface consists of a front panel keypad
4
and LCD display. The user is able to adjust cycle mode and vacuum level based on personal comfort and preference.
The purpose of this 510(k) is to update the indications for use statement to include use by multiple users. The labeling has been revised to clarify that the collection kits are for single users only and are not to be shared with other users.
Device Comparison Table:
| | New Device | Predicate Device | Substantial
Equivalence
Comparison |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Lansinoh Laboratories
Saglik Gerecleri Tasarim
San. Tic. Ltd. Sti. | Lansinoh Laboratories
Saglik Gerecleri
Tasarim San. Tic. Ltd.
Sti. | N/A |
| Device Name | Lansinoh® Signature
Pro™ Double Electric
Breast Pump (DEBP 2.1)
and Lansinoh®
Smartpump™ Double
Electric Breast Pump
(DEBP 2.2) | Powered Breast Pump | N/A |
| 510(k) # | K182749 | K122474 | N/A |
| Intended Use | The Lansinoh® Signature
Pro™ 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
multiple users, and single
users.
The Lansinoh®
Smartpump™ 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 multiple | The Powered Breast
Pump is intended to
express and collect the
breast milk of a nursing
woman for the purpose
of feeding the collected
milk to a baby. The
Powered Breast Pump is
intended for a single
user. | Different; the
indications for use of
the subject devices are
different from the
predicate in that the
subject device is
intended for multiple
users. However, this
difference does not alter
the intended use of the
device as compared to
the predicate. |
| | New Device | Predicate Device | Substantial
Equivalence
Comparison |
| | users, and single users. | | |
| Suction Levels
(stimulation) | 46-140 mmHg | 55 - 140 mmHg | Similar; the subject
devices have a slightly
lower suction level.
However, this difference
does not raise different
questions of safety and
effectiveness. |
| Cycles per Second
(stimulation) | 1.61-2.33 | 1.55 - 2.4 | Similar; the subject
devices have a slightly
different cycle rates.
However, this difference
does not raise different
questions of safety and
effectiveness. |
| Suction Levels
(expression) | 95 - 280 mmHg | 80 – 220 mmHg | Different; the subject
device has higher
pressure levels for
expression than the
predicate. However,
this difference does not
raise different questions
of safety and
effectiveness. |
| Cycles per Second
(expression) | 0.58 - 1.69 | 0.61 - 1.52 | Similar; the subject
devices have a slightly
different cycle rate.
However, this difference
does not raise different
questions of safety and
effectiveness. |
| Suction Settings | 8 | 8 | Same |
| Expression modes | 3 | 3 | Same |
| Power Supply | a) 6 AA alkaline batteries
b) AC Adapter | a) 6 AA alkaline
batteries
b) AC Adapter | Same |
| Pumping Option | Single or Double | Single or Double | Same |
| Back Flow
Protection | Yes | Yes | Same |
| Let Down Function | Yes | Yes | Same |
| | New Device | Predicate Device | Substantial
Equivalence
Comparison |
| Cycling/Suction
Control Mechanism | Microprocessor | Microprocessor | Same |
| Communication
with mobile app
(Smartpump only) | Bluetooth | N/A | Different; the subject
device (SmartPump) has
Bluetooth capability.
The addition of
Bluetooth
communication does not
alter the intended use or
raise different questions
of safety and
effectiveness. |
5
6
Performance Data:
Bench Performance
Suction Curves
Devices were evaluated for suction performance at each of the available settings. The suction curves for each cycle mode and suction level demonstrated that the device meets its specifications and performs within the specified working ranges of pressure and cycle speed for each mode/level.
Battery Life Testing
Battery life was measured with the pumps at the highest level ((Expression Mode 3, Level 8). The "fail time" was defined as the number of minutes the pump could run at this level before dropping below specifications. Testing supports that the battery life of the device, as noted in the labeling, is approximately 90 minutes.
Sterilization, Cleaning and Shelf Life
Sterilization and Cleaning
The device is reusable, provided non-sterile, and is not sterile when used. Cleaning instructions are provided in the labeling.
Shelf-life
Shelf-life is not applicable due to the low likelihood of time-dependent product degradation. However, in accordance with IEC 60601-1:2005/(R)2012 the subject devices expected use-life is 500 hours. In testing, the devices were demonstrated to operate within specifications for up to 500 hours of continuous operation at the maximum setting (Expression mode 3, Level 8).
Backflow Test
The Lansinoh pumps are designed as a closed milk collection system. The diaphragm provides a physical barrier, preventing breastmilk from flowing into the tubing or pump body. The purpose
7
of the backflow test is to demonstrate that the design prevents backflow into the tubing and pump. Devices were tested at maximum pressure/cycle settings (Expression Mode 3, Level 8) at various orientations to simulate worst-case conditions. The testing demonstrated that no milk was present in test devices' tubing during and following the test; therefore the diaphragm was demonstrated to prevent back flow of milk into the tubing and pump.
Biocompatibility
There have been no changes to the patient contacting materials used in the subject device since its previous clearance in K122474. Therefore, biocompatibility data from K122474 can be leveraged to support the biocompatibility of the subject devices.
The milk contacting components are those components that are provided in the pump kit. All materials in contact with milk have been tested to meet FDA's Food Additive criteria (21 CFR 175-179).
Electrical Safety and EMC
The device was tested for electrical safety in accordance with (ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012) and EMC in accordance with (IEC 60601-1-2:2007). The device was demonstrated to meet applicable test limits for electrical safety and EMC per the cited standards.
Software and Cybersecurity
The software was evaluated as a minor level of concern per FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005. Documentation consistent with a minor level of concern demonstrated the software functions as intended.
Cybersecurity for the subject devices was evaluated through a risk-based approach. Appropriate mitigations were implemented based upon the level of risk of the devices.
Substantial Equivalence Conclusion:
The purpose of this 510(k) is to establish substantial equivalence of the Lansinoh® Signature Pro™ Double Electric Breast Pump (DEBP 2.1) and Lansinoh® Smartpump™ Double Electric Breast Pump (DEBP 2.2) to the previously cleared Lansinoh Double Electric Breast Pump (K122474).
The subject device indications are different from that of the predicate in that they allow for multiple users. This difference does not alter the intended use of the subject device from that of the predicate.
The subject devices have slightly different technological characteristics as described in the table above. However, the technological differences do not alter the intended use of the subject device as compared to the predicate or raise different questions of safety and effectiveness. The technological differences were evaluated through performance testing that demonstrated that the subject device is as safe and effective as the predicate.
Therefore, the subject devices are substantially equivalent to the predicate.