(149 days)
The Elvie Stride is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Elvie Stride is intended for a single user.
Elvie Stride is an electric breast pump that is intended for lactating women to express and collect breast milk. It is intended for a single user. It may be operated as a single or double pumping system. Elvie Stride has adopted the in-bra aesthetic. It is designed to work in the user's nursing bra and has a rechargeable battery so it can be used hands-free without any external power cords. The pump is located off the body and the milk collection bottle is located on the breast. It expresses milk by applying negative pressure to the nipple so that expressed milk may collect in the milk collection bottle. It can be controlled through the physical interface on the pump or through a mobile companion app. Elvie Stride consists of 15 components: Hub, Breast Shield, Cup Front, Diaphragm Seal, Valve, Stopper, Tubing, Tube Splitter, Hub Connector, Cover, Cup Seal, Cap, Cap Seal, Clip and USB Charging Cable. All components are reusable and may be manually cleaned or placed on the top shelf of a dish washer.
This document is a 510(k) premarket notification for the Elvie Stride, a powered breast pump. It primarily focuses on demonstrating substantial equivalence to a predicate device (Elvie Pump K181863), not on clinical performance studies that would typically involve acceptance criteria for an AI/software as a medical device (SaMD).
Therefore, the provided text does not contain the information required to answer the prompt regarding acceptance criteria and the study proving a device meets those criteria, specifically in the context of an AI/SaMD.
The document details:
- Device Type: Powered breast pump (hardware device, not an AI/SaMD).
- Approval Type: 510(k) Premarket Notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical performance against pre-defined acceptance criteria for, say, diagnostic accuracy.
- Non-Clinical Testing: Biocompatibility, electrical safety, electromagnetic compatibility, wireless technology, software verification (for the breast pump's internal software, not an AI for diagnosis), and performance testing (e.g., vacuum pressure, cycle rate, backflow, battery life).
To illustrate, if this were an AI/SaMD for, for example, breast cancer detection, the information I would expect to find (but is absent here) would be:
- A table of acceptance criteria and the reported device performance: This would list metrics like sensitivity, specificity, AUC, or F1-score with defined thresholds and the actual values achieved in a clinical study.
- Sample size and data provenance: Details on the number of images/cases in the test set, their origin (e.g., US hospitals, European clinics), and whether the data was collected retrospectively or prospectively.
- Number of experts and qualifications for ground truth: How many radiologists or pathologists reviewed the data to establish the definitive diagnosis, and their experience levels.
- Adjudication method: How disagreements among experts were resolved (e.g., majority vote, senior expert review).
- MRMC study and effect size: If human performance with and without AI assistance was compared, and the quantitative improvement.
- Standalone performance: The AI's performance without human intervention.
- Type of ground truth: Whether it was expert consensus, biopsy-confirmed pathology, or long-term clinical outcomes.
- Training set sample size: How many cases were used to train the AI.
- Ground truth for training set: How the training data labels were established.
Since the provided document is for a physical breast pump and not an AI/SaMD, none of this detailed information about AI performance or clinical study design elements for AI validation is present. The "Testing" section refers to engineering and safety tests for the breast pump itself, not diagnostic performance of an AI.
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August 25, 2021
Chiaro Technology Limited % Marc C. Sanchez, Esq. Regulatory Attorney Contract In-House Counsel and Consultants, LLC d/b/a FDA Atty 53516 Bickett Chapel Hill, NC 27517
Re: K210936
Trade/Device Name: Elvie Stride Regulation Number: 21 CFR$ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: July 21, 2021 Received: July 28, 2021
Dear Marc C. Sanchez:
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.
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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 (OS) 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,
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) K210936
Device Name Elvie Stride
Indications for Use (Describe)
The Elvie Stride is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Elvie Stride 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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K210936 Page 1 of 4
510(K) Summary
K210936
Submitter Information:
| Sponsor: | Chiaro Technology Limited63-66 Hatton GardenLondon EC1N 8LE United KingdomEstablishment Registration: 3012098706 |
|---|---|
| Manufacturer: | Sanmina-SCI Systems De Mexico SA De CVKm 15.5 No. 29, Plant 06Carr. Chapala-Guadalajara Jalisco, MX 45640Establishment Registration: 3006544299 |
| Contact: | Marc C. Sanchez, Esq.Contract In-House Counsel and Consultants, LLC53516 Bickett Chapel Hill NC 27517Ph: 202.765.4491E-mail: msanchez@fdaatty.com |
Date 510(k) Summary Prepared: August 23, 2021
Device Information:
| Device/Trade Name: | Elvie Stride |
|---|---|
| Common Name: | Powered breast pump |
| Regulation Name: | Powered breast pump |
| Regulation Number: | 21 CFR 884.5160 |
| Product Code: | HGX (Pump, Breast, Powered) |
| Regulatory Class: | Class II |
| Review Panel: | Obstetrics/Gynecology |
Predicate Device:
| 510(k) Number: | K181863 |
|---|---|
| Manufacturer: | Chiaro Technology Limited |
| Device Name: | Elvie Pump |
The predicate device has not been subject to a design-related recall.
Device Description:
Elvie Stride is an electric breast pump that is intended for lactating women to express and collect breast milk. It is intended for a single user. It may be operated as a single or double pumping system.
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Elvie Stride has adopted the in-bra aesthetic. It is designed to work in the user's nursing bra and has a rechargeable battery so it can be used hands-free without any external power cords. The pump is located off the body and the milk collection bottle is located on the breast. It expresses milk by applying negative pressure to the nipple so that expressed milk may collect in the milk collection bottle. It can be controlled through the physical interface on the pump or through a mobile companion app.
Elvie Stride consists of 15 components: Hub, Breast Shield, Cup Front, Diaphragm Seal, Valve, Stopper, Tubing, Tube Splitter, Hub Connector, Cover, Cup Seal, Cap, Cap Seal, Clip and USB Charging Cable. All components are reusable and may be manually cleaned or placed on the top shelf of a dish washer.
Indications for Use:
The Elvie Stride is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Elvie Stride is intended for a single user.
Comparison of Intended Use and Technological Characteristics:
The following table compares the subject device to the predicate device with respect to the indications for use and technological characteristics:
| Attribute | Subject DeviceElvie StrideK210936 | Predicate DeviceElvie PumpK181863 | Comparison |
|---|---|---|---|
| Indications for Use | The Elvie Stride is a poweredbreast pump to be used bylactating women to expressand collect milk from theirbreasts. The Elvie Stride isintended for a single user. | The Elvie Pump is a poweredbreast pump to be used bylactating women to express andcollect milk from their breasts.The Elvie Pump is intended for asingle user. | Identical |
| Intended Use | Express milk from breast | Express milk from breast | Identical |
| Single User Device | Yes | Yes | Identical |
| Single / Double Pumping | Both | Both | Identical |
| Patient Population | Lactating women | Lactating women | Identical |
| Environment of Use | Home | Home | Identical |
| Over the Counter | Yes | Yes | Identical |
| Power Source | USB cable (battery charger)and Li-Ion Battery | USB cable (battery charger) andLi-Polymer Battery | Different |
| Adjustable SuctionLevels | Yes | Yes | Identical |
| Backflow Protection | Yes | Yes | Identical |
| Suction Strength | 35-260 mmHg (double)55-300 mmHg (single) | 40-220 mmHg | Different |
| Maximum SuctionStrength | 300 mmHg | 220 mmHg | Different |
| Cycle Speed | 31 to 83 cycles/min(Stimulation)18 to 51 cycles/min(Expression) | 1.1 to 2.0 cycles per/sec(Stimulation)0.6 to 1.0 cycles/sec(Expression) | Different |
| Expression levels | 10 | 7 | Different |
| Pump Type | Rotary Electric Pump | Piezoelectric Pump | Different |
| Two-phase Expression | Yes | Yes | Identical |
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| User Controls | On pump body and/or throughapp | On pump body and/or throughapp | Identical |
|---|---|---|---|
| Control Mechanism | Microcontroller | Microcontroller | Identical |
| Mobile App | Yes | Yes | Identical |
| Milk QuantityMeasurement | No | Yes | Different |
The subject and predicate device have the same intended use – to express and collect milk from lactating women. The subject and predicate device have different technological features, including the power source, suction strength, pump type, and milk quantity measurement. These technological differences do not raise different questions of safety or effectiveness.
Summary of Non-Clinical Testing:
Non-clinical tests were conducted to verify that the proposed device met all design specifications and that the subject devices are substantially equivalent to the predicate device.
-
Biocompatibility a.
Biocompatibility testing in accordance with the FDA guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" dated September 4, 2020. Testing included the following assessments: -
Cytotoxicity per ISO 10993-5:2009 Biological evaluation of medical devices --● Part 5: Tests for in vitro cytotoxicity
-
. Sensitization per ISO 10993-10:2010 Biological evaluation of medical devices --Part 10: Tests for irritation and skin sensitization
-
Irritation per ISO 10993-10:2010 Biological evaluation of medical devices -- Part . 10: Tests for irritation and skin sensitization
The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
- b. Electrical Safety, Electromagnetic Compatibility, and Wireless Technology
- IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical electrical ● equipment - Part 1: General requirements for basic safety, and essential performance with US deviations per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012.
- 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.
- IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility
- . IEC 62133:2012 - 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
- Documentation provided in accordance with the FDA Guidance document, "Radio Frequency Wireless Technology in Medical Devices" dated August 14, 2013.
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-
Software Verification c.
Software verification and validation in accordance with the FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005. -
d. Performance Testing
- Vacuum pressure and cycle rate testing was conducted at all settings and . demonstrated that the device met its specifications.
- . Backflow testing was conducted to demonstrate that liquid does not backflow into the tubing/pump.
- . 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.
Conclusion:
The comparison and analysis above demonstrate that the Elvie Stride is as safe and effective as the predicate device and supports a determination of substantial equivalence to the predicate device.
§ 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).