(256 days)
Not Found
No
The description focuses on standard breast pump functionality, adjustable vacuum levels, pre-programmed modes, and battery operation. There is no mention of AI, ML, or any features that would suggest adaptive learning or intelligent processing of data.
No
The device, a breast pump, is used to express and collect milk, not to treat or diagnose a disease or condition for therapeutic purposes.
No.
The device is a powered breast pump intended to express and collect milk, not diagnose a medical condition.
No
The device description explicitly states it is a "powered breast pump" and mentions hardware components like a battery, motor (implied by "powered"), and physical components designed to work in a bra. It also details non-clinical tests related to hardware performance and safety.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Spectra Wearable is a breast pump. Its function is to physically express and collect breast milk from a lactating woman. It does not analyze any biological specimens to provide diagnostic information.
- Intended Use: The intended use is to "express and collect milk from their breasts." This is a mechanical process, not a diagnostic test.
Therefore, the Spectra Wearable falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HGX
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breasts
Indicated Patient Age Range
Lactating women
Intended User / Care Setting
Home use by a single user.
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)
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:
-
- Electromagnetic Compatibility and Electrical Safety
-
- 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.
-
- Biocompatibility: Cytotoxicity per ISO 10993-5:2009/(R)2014; Sensitization per ISO 10993-10:2010; Irritation per ISO 10993-10:2010. 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.
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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
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-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
2
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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3
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 |
4
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.
5
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 for | |||
| Use | The Spectra Wearable is | ||
| a powered breast pump | |||
| to be used by lactating | |||
| women to stimulate, | |||
| express and collect milk | |||
| from their breasts. The | |||
| Spectra Wearable is | |||
| intended for home use | |||
| by a single user. | The imani i2 breast pump | ||
| is a powered breast pump | |||
| to be used by lactating | |||
| women to express and | |||
| collect milk from their | |||
| breasts. The imani i2 | |||
| breast pump is a single | |||
| user device. | Similar | ||
| Single user | |||
| device | Single user | Single user | Same |
| Submission | |||
| Number | 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 breast | ||
| pump | |||
| Wearable cover | |||
| Wearable breast | |||
| shield | |||
| Wearable silicone | |||
| membrane | |||
| Wearable silicone | |||
| valve | |||
| Wearable bottle | |||
| Bottle connector | |||
| Connector pin | |||
| Airtight cap | |||
| PP bottle | |||
| Nipple | |||
| Screw cap | |||
| Cover | |||
| Adapter | Breast Funnel (sizes: | ||
| 25mm and 28 mm [32 | |||
| mm sold separately]) | |||
| Collection Bottle | |||
| Valve | |||
| Diaphragm Backflow | |||
| Protector | |||
| Connector | |||
| Charging cable | Different | ||
| Cleaning | |||
| method | Wash and sanitize | Wash and sanitize | Same |
| Specifications | |||
| Power sources | Rechargeable Li-Polymer | ||
| Battery | Rechargeable Li-Polymer | ||
| Battery | Same |
| Table 1. Comparison of Subject Device to Predicate Devices | |
|---|---|
| ------------------------------------------------------------ | -- |
6
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Suction | |||
| strength | Expression mode: 100 - | ||
| 270 mmHg, 5 levels | |||
| Massage mode: 50 - 130 | |||
| mmHg, 5 levels | Pumping mode: 80 - 270 | ||
| mmHg, 5 levels | |||
| Massage mode: 50 – 150 | |||
| mmHg, 5 levels | Different | ||
| Cycle speed | Pumping mode: 12 – 53 | ||
| CPM | |||
| Massage mode: 60 - 100 | |||
| CPM | Pumping mode: 24 – 55 | ||
| CPM | |||
| Massage mode: 65 CPM | Different | ||
| Backflow | |||
| Protection | 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:
| Standards
No. | Standards
Organization | Standard Title | Version | Publication
Year |
|------------------|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|---------------------|
| ES60601-1 | AAMI ANSI | Medical Electrical Equipment - Part 1: General
Requirements for Basic Safety and Essential
Performance (IEC 60601-1:2005, MOD) | ES60601-1:
2005(R)201
2 and
A1:2012 | 2014 |
| 60601-1-2 | IEC | Medical Electrical Equipment - Part 1-2:
General Requirements for Safety - Collateral
Standard: Electromagnetic Compatibility -
Requirements and Tests | 60601-1-2
Edition 4.0
2014-02 | 2016 |
| 60601-1-11 | IEC | 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 | 60601-1-11
Edition 2.0
2015-01 | 2016 |
-
- 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
7
- . 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.