(231 days)
A personal use electric powered device used to express milk from the breast of lactating women. The device is not intended for hospital use
The Simplisse Electric Breastfeeding Companion is a personal use electric powered device used to express milk from the breast of lactating women.
N/A
Section 5: 510(k) Summary
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1.0 Submitted By
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
3.2 Common Name:
Powered Breast Pump
3.3 Classification Name
Electric Breast Pump (21CFR 884.5160, Product code - HGX)
4.0 Predicate Devices:
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| 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 | Yes | Yes | Yes | Yes |
| Power Source | 1. AC Power Cord2. 6 AA Batteries | 1. AC Power Cord | 1. AC Power Cord2. 6 AA Batteries | 1. AC Power Cord2. 12 V Car Adapter |
| Control Mechanism | Microprocessor | Mechanical | Microprocessor | Mechanical |
| Pump Type | Reciprocating Piston | Reciprocating Diaphragm | Reciprocating Piston | Reciprocating Diaphragm |
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| Single or Double Breast Pumping | Both | Both | Both | Both |
|---|---|---|---|---|
| Adjustable Suction Levels | Yes | Yes | Yes | Yes |
| Adjustable 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
10903 New Hampshire Avenue
Document Mail Center - W066-G609
Silver Spring, MD 20993-0002
Simplisse Inc.
c/o Mr. Glen Feye
President
Accurate Consultants, Inc.
1340 West Pennsylvania Ave.
SAN DIEGO CA 92103
Re: K093648
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.
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 (reporting of medical device-related
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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/ResourcesforYou/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
Enclosure
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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 _____ AND/OR Over-The-Counter Use X
(Part 21 CFR 801 Subpart D) (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 K093648
§ 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).