(256 days)
The Spectra Wearable is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Spectra Wearable is intended for a single user.
The SPECTRA WEARABLE is a powered breast pump that is intended to express and collect milk from the breasts of lactating women. This breast pump is intended for use by a single user and can be used to pump breast milk from a single breast (single pumping). It is designed to work in the user's bra and is battery operated so it can be used hands-free without external power cords. The device is provided non-sterile. The SPECTRA WEARABLE allows the user to adjust the vacuum levels. Two suction patterns, massage and expression mode, are pre-programmed with variable levels and cycle speeds. The subject device is powered by a rechargeable Li-polymer battery (3.7 V, 1500 mAh).
The provided text describes the 510(k) summary for the SPECTRA WEARABLE powered breast pump (K220926). This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to existing ones and ensuring it meets safety and performance standards, rather than proving its effectiveness through clinical trials with specific acceptance criteria in the way a new therapeutic drug or medical imaging AI might.
Therefore, the requested information regarding acceptance criteria and studies (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) is not typically found in these types of submissions for a device like a powered breast pump. The focus is on technical performance, safety, and substantial equivalence to a predicate device, rather than a clinical effectiveness study with defined endpoints and ground truth.
However, based on the provided text, I can extract the following relevant information regarding the non-clinical tests conducted to demonstrate substantial equivalence and general performance.
Acceptance Criteria and Device Performance (Inferred from Non-Clinical Tests)
| Acceptance Criteria (Inferred from Standards & Testing) | Reported Device Performance (Summary of Test Results) |
|---|---|
| Electrical Safety (ES60601-1) | Met general requirements for basic safety and essential performance. |
| Electromagnetic Compatibility (60601-1-2) | Met requirements for electromagnetic compatibility. |
| Home Healthcare Environment Safety (60601-1-11) | Met general requirements for basic safety and essential performance for devices used in the home healthcare environment. |
| Software Validation (FDA Guidance) | Software documentation was provided in accordance with FDA guidance, implying the software performs as intended and is safe. |
| Biocompatibility (ISO 10993-5, -10) | Patient-contacting components were found to be non-cytotoxic, non-sensitizing, and non-irritating. |
| Vacuum Performance (Minimum & Maximum Settings) | Specifications were met for vacuum level (Expression mode: 100-270 mmHg, 5 levels; Massage mode: 50-130 mmHg, 5 levels). |
| Cycle Performance (Minimum & Maximum Settings) | Specifications were met for cycle rate (Pumping mode: 12-53 CPM; Massage mode: 60-100 CPM). |
| Backflow Protection | Specifications were met for backflow protection. |
| Use Life | The device demonstrated maintenance of its performance specifications throughout its proposed use-life during use life testing. |
| Battery Performance | The battery remained functional during its stated battery use-life. |
| Battery Status Indicator | The battery status indicator remained functional during its stated battery life. |
Here's a breakdown of the specific points requested, based on the absence or presence of information in the document:
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A table of acceptance criteria and the reported device performance
- See table above. The "acceptance criteria" are inferred from the standards and tests performed, which aim to ensure safety and performance equivalence to the predicate device. The "reported device performance" is the summary of the test results indicating that these criteria were met.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in the document. The testing described is primarily engineering and bench testing (e.g., electrical safety, EMC, biocompatibility, vacuum performance), not a clinical study involving a "test set" of patients or data in the typical sense.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not provided and is not applicable to the types of non-clinical, bench testing performed for this device. "Ground truth" in this context would refer to objective measurements and compliance with established engineering and safety standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided and is not applicable to the types of non-clinical tests performed.
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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 diagnostic devices, particularly those involving human interpretation of imaging, often with AI assistance. The SPECTRA WEARABLE is a powered breast pump, a mechanical device, not a diagnostic tool where "human readers" would be involved in interpreting results.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable as the device is a mechanical breast pump and does not involve an "algorithm only" or AI component in the sense of image analysis or diagnostic prediction. Its performance is evaluated through physical and electrical testing.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests described is based on established engineering specifications, regulatory standards, and objective measurements. For example, a vacuum gauge would objectively measure vacuum strength against a specified range, and a timer would measure cycle speed. Biocompatibility is assessed against ISO standard criteria.
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The sample size for the training set
- This information is not provided and is not applicable. The device is a mechanical breast pump; it does not utilize a machine learning model that requires a "training set."
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How the ground truth for the training set was established
- This information is not applicable as there is no training set for this device.
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December 12, 2022
Uzinmedicare Co., Ltd. % Im Dogyun Senior Researcher GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul, Mapo-gu 03909 Korea. South
Re: K220926
Trade/Device Name: SPECTRA WEARABLE Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: November 2, 2022 Received: November 7, 2022
Dear Im Dogyun:
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-regulatory-information/postmarketing-safety-reportingcombination-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.
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) K20220926
Device Name SPECTRA WEARABLE
Indications for Use (Describe)
The Spectra Wearable is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Spectra Wearable is intended for a single user.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☐ Exporting to the US (via EEI/AES filing) |
|---|
| ☑ Import - The goods are being imported into the US |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary — K220926
1. Date Prepared
December 9, 2022
2. Submitter's Information
- Name of Manufacturer: Uzinmedicare Co., Ltd.
- Address: 56, Dongtansandan 5-gil, Hwaseong-si, Gyeonggi-do, Republic of Korea
- Contact Name: JANG dain
- Telephone No.: +82 10-4740-0423
- Email Address: jdi0503@uzinmediar.com
- Registration No.: 301139154
3. Trade Name, Common Name, Classification
| 510(k) Number | K220926 |
|---|---|
| Trade Name | SPECTRA WEARABLE |
| Common Name | Powered Breast Pump |
| Regulation Number | 21 CFR 884.5160 |
| Regulation Name | Powered breast pump |
| Product Code | HGX (Pump, Breast, Powered) |
| Regulatory Class | II |
| 510(k) Review Panel | Obstetrics/Gynecology |
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4. Identification of Predicate Device
| 510(k) Number | K202037 |
|---|---|
| Trade/Device/Model Name | imani i2 |
| Regulation Number | 21 CFR 884. 5160 |
| Classification Product Code | HGX |
| Device Class | II |
The predicate device has not been subject to a design-related recall.
5. Device Description
The SPECTRA WEARABLE is a powered breast pump that is intended to express and collect milk from the breasts of lactating women. This breast pump is intended for use by a single user and can be used to pump breast milk from a single breast (single pumping). It is designed to work in the user's bra and is battery operated so it can be used hands-free without external power cords. The device is provided non-sterile. The SPECTRA WEARABLE allows the user to adjust the vacuum levels. Two suction patterns, massage and expression mode, are pre-programmed with variable levels and cycle speeds. The subject device is powered by a rechargeable Li-polymer battery (3.7 V, 1500 mAh).
6. Indications for use
The Spectra Wearable is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Spectra Wearable is intended for a single user.
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7. Comparison of Intended Use and Technological Characteristics
The intended use and key technological characteristics of the subject and predicate device are compared in the table below.
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Product Name | Powered Breast Pump | Powered Breast Pump | N/A |
| Model Name | SPECTRA WEARABLE | imani i2 | N/A |
| Manufacturer | Uzinmedicare co., Ltd. | imani Co. | N/A |
| Indications forUse | The Spectra Wearable isa powered breast pumpto be used by lactatingwomen to stimulate,express and collect milkfrom their breasts. TheSpectra Wearable isintended for home useby a single user. | The imani i2 breast pumpis a powered breast pumpto be used by lactatingwomen to express andcollect milk from theirbreasts. The imani i2breast pump is a singleuser device. | Similar |
| Single userdevice | Single user | Single user | Same |
| SubmissionNumber | K220926 | K202037 | N/A |
| Product Code | HGX | HGX | Same |
| Device Class | II | II | Same |
| Sterility | Not sterile | Not sterile | Same |
| User Interface and Controls | |||
| Design | Wearable pump | Wearable pump | Same |
| Pump Options | Single | Single | Same |
| Accessories | Wearable breastpumpWearable coverWearable breastshieldWearable siliconemembraneWearable siliconevalveWearable bottleBottle connectorConnector pinAirtight capPP bottleNippleScrew capCoverAdapter | Breast Funnel (sizes:25mm and 28 mm [32mm sold separately])Collection BottleValveDiaphragm BackflowProtectorConnectorCharging cable | Different |
| Cleaningmethod | Wash and sanitize | Wash and sanitize | Same |
| Specifications | |||
| Power sources | Rechargeable Li-PolymerBattery | Rechargeable Li-PolymerBattery | Same |
| Table 1. Comparison of Subject Device to Predicate Devices | |
|---|---|
| ------------------------------------------------------------ | -- |
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| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Suctionstrength | Expression mode: 100 -270 mmHg, 5 levelsMassage mode: 50 - 130mmHg, 5 levels | Pumping mode: 80 - 270mmHg, 5 levelsMassage mode: 50 – 150mmHg, 5 levels | Different |
| Cycle speed | Pumping mode: 12 – 53CPMMassage mode: 60 - 100CPM | Pumping mode: 24 – 55CPMMassage mode: 65 CPM | Different |
| BackflowProtection | Yes | Yes | Same |
The subject and predicate device have similar indications for use statements and the same intended use – to express and collect milk from lactating women. The subject and predicate device have different technological characteristics, including different accessories, suction strengths, and cycle speeds. However, the differences in technological characteristics do not raise different questions of safety and effectiveness.
8. Non-Clinical Test summary
Non-clinical tests were conducted to verify that the proposed device met all design specification and that they subject device is substantially equivalent to the predicate device. The subject device has been tested as follows:
| StandardsNo. | StandardsOrganization | Standard Title | Version | PublicationYear |
|---|---|---|---|---|
| ES60601-1 | AAMI ANSI | Medical Electrical Equipment - Part 1: GeneralRequirements for Basic Safety and EssentialPerformance (IEC 60601-1:2005, MOD) | ES60601-1:2005(R)2012 andA1:2012 | 2014 |
| 60601-1-2 | IEC | Medical Electrical Equipment - Part 1-2:General Requirements for Safety - CollateralStandard: Electromagnetic Compatibility -Requirements and Tests | 60601-1-2Edition 4.02014-02 | 2016 |
| 60601-1-11 | IEC | Medical electrical equipment - Part 1-11:General requirements for basic safety andessential performance - Collateral Standard:Requirements for medical electrical equipmentand medical electrical systems used in thehome healthcare environment | 60601-1-11Edition 2.02015-01 | 2016 |
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- Electromagnetic Compatibility and Electrical Safety
2) Software Validation
- The software documentation of the subject device was provided in accordance with FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005.
3) Biocompatibility
- Cytotoxicity per ISO 10993-5:2009/(R)2014, Biological evaluation of medical devices Part 5: • Tests for in vitro cytotoxicity
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- . Sensitization per ISO 10993-10:2010, Biological evaluation of medical devices - Part 10L 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 results of these tests demonstrated that the patient-contacting components of the subject device are non-cytotoxic, non-sensitizing, and non-irritating.
-
- Performance Testing
- . Vacuum performance testing, cycle performance testing, and backflow protection testing was conducted at minimum and maximum vacuum settinqs to determine the minimum and maximum vacuum levels of the pump as compared to its specifications. The specifications were met for vacuum level, cycle rate, and backflow protection.
- . Use life testing was conducted to demonstrate that the device maintains its performance 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.
9. Conclusion
The results of the testing described above demonstrate that the subject device is as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 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).