(231 days)
Not Found
No
The summary describes a standard electric breast pump and does not mention any AI or ML capabilities.
Yes.
The device is intended to express milk from the breast of lactating women to meet a physiological need, which aligns with the definition of a therapeutic device.
No
The device's intended use is to express milk, not to diagnose a condition or disease.
No
The device description explicitly states it is an "electric powered device," indicating it includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device function: The description clearly states the device is used to "express milk from the breast of lactating women." This is a physical process of extracting a bodily fluid, not a test performed on a sample of that fluid to diagnose or monitor a condition.
- Lack of diagnostic testing: There is no mention of analyzing the milk for any diagnostic purpose. The device's function is solely to collect the milk.
Therefore, based on the provided information, the Simplisse Electric Breastfeeding Companion is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Simplisse Electric Breastfeeding Companion is a personal use electric powered device used to express milk from the breast of lactating women. The device is not intended for hospital use
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Lactating women
Intended User / Care Setting
personal use
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)
Testing of the device has demonstrated that the Simplisse Electric Breastfeeding Companion meets established requirements when used in the manner and environment specified in product labeling.
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
K093648 page 1 of 3
JUL 1 4 2010
Section 5: 510(k) Summary
Submitted By: 1.0
Simplisse Inc. 4433 Fyler Ave St. Louis, MO 63116 Establishment Registration Number: None
Primary Contact: Glen Feye, President Accurate Consultants, Inc. 1340 West Pennsylvania Ave. San Diego, CA 92103 Telephone: 619-291-3695 Fax: 619-393-0582 glenfeye@earthlink.net
2.0 Date Submitted:
November 30, 2009
3.0 Device Name(s):
3.1 Trade Name:
Simplisse Electric Breastfeeding Companion
Common Name: 3.2
Powered Breast Pump
3.3 Classification Name
Electric Breast Pump (21CFR 884.5160, Product code - HGX )
4.0 Predicate Devices:
1
| Candidate | Predicates | Manufacturer | Docket Number |
|---|---|---|---|
| Simplisse | |||
| Electric | |||
| Breastfeeding | |||
| Companion | Medela's Pump In | ||
| Style | Medela Inc. | K950750 | |
| Ameda-Egnell | |||
| Purely Yours | Ameda | ||
| Medizintechnik AG | K973501 | ||
| Even Flo Comfort | |||
| Control | Evenflow Co., Inc. | K983776 |
5.0 Intended Use:
The Simplisse Electric Breastfeeding Companion is a personal use electric powered device used to express milk from the breast of lactating women. The device is not intended for hospital use
6.0 Comparison to Predicate Devices:
The following table summarizes the basic similarities and differences between the candidate- Simplisse Electric Breastfeeding Companion and the predicates identified in Section 4.0 of this 510(k) Summary section.
| Characteristic | Candidate | Predicates | ||
|---|---|---|---|---|
| Name | Simplisse Electric | |||
| Breastfeeding | ||||
| Companion | Medela Pump | |||
| In Style | Ameda-Egnell | |||
| Purely Yours | Even Flo | |||
| Comfort | ||||
| Control | ||||
| 510(k) No. | None | K950750 | K973501 | K983776 |
| Intended Use | To Express Milk | To Express | ||
| Milk | To Express Milk | To Express | ||
| Milk | ||||
| Materials -21 | ||||
| CFR Parts | ||||
| 176, 177, and | ||||
| 178 | ||||
| compliant. | Yes | Yes | Yes | Yes |
| Power Source | 1. AC Power Cord | 1. AC Power | ||
| Cord | 1. AC Power | |||
| Cord | ||||
| 2.6 AA Batteries | 1. AC Power | |||
| Cord |
- 12 V Car
Adapter |
| Control
Mechanism | Microprocessor | Mechanical | Microprocessor | Mechanical |
| Pump Type | Reciprocating
Piston | Reciprocating
Diaphragm | Reciprocating
Piston | Reciprocating
Diaphragm |
2
| Single or
Double Breast
| Pumping | Both | Both | Both | Both |
|---|---|---|---|---|
| Adjustable | ||||
| Suction | ||||
| Levels | Yes | Yes | Yes | Yes |
| Adiustable | ||||
| Cycle Speed | Yes | Yes | Yes | Yes |
| Overflow | ||||
| Protection | Yes | No | Yes | Yes |
| Breast Cup-to | ||||
| Breast | ||||
| Interface | Thermoplastic | |||
| Elastomer and Rigid | ||||
| Plastic | Rigid Plastic | Rigid Plastic | ||
| (Partial Silicone | ||||
| covering | ||||
| available) | Rigid Plastic | |||
| Active Breast | ||||
| Massage | Yes | No | No | No |
| Weight | 4-5 pounds | 7-8 pounds | 5-6 pounds | 3-5 pounds |
Design and Materials
All milk and human contact components from the Simplisse Electric Breastfeeding Companion and the predicates are manufactured from materials that meet FDA food additive criteria as set forth in Part 21 Code of Federal Regulations Parts 176, 177, and 178. In addition, the Breast Cup has been tested for biocompatibility per established guidelines.
7.0 Summary of Non-Clinical Performance Data:
Testing of the device has demonstrated that the Simplisse Electric Breastfeeding Companion meets established requirements when used in the manner and environment specified in product labeling.
8.0 Conclusion:
The Simplisse Electric Breastfeeding Companion is substantially equivalent to its predicate devices. Based upon the test data submitted, the device provides sufficient vacuum pressure to safely and effectively express and collect milk from lactating women.
3
Image /page/3/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, consisting of three curved lines representing the eagle's body and wings. The eagle's head is suggested by a small, pointed shape at the right side of the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES,
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Simplisse Inc. c/o Mr. Glen Feve President Accurate Consultants, Inc. 1340 West Pennsylvania Ave. SAN DIEGO CA 92103
Re:
Trade Name: Simplisse Electric Breastfeeding Companion Regulation Number: 21 CFR §884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: July 7, 2010 Received: July 9, 2010
Dear Mr. Feye:
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. 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.
JUL 1 4 2010
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. 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
4
Enclosure.
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices office of Device Evaluation Center for Devices and Radiological Health
5
Section 4: Indications for Use Statements
Indications for Use
510(k) Number (if known):
Device Name: Simplisse Electric Breastfeeding Companion
Indications for Use:
A personal use electric powered device used to express milk from the breast of lactating women.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number
Simplisse Inc. Section 510(k) Notification Powered Breast Pump