MAM TWISTER

K092781 · Mam International AG · KKO · Jun 23, 2010 · Dental

Device Facts

• Record ID: K092781
• Device Name: MAM TWISTER
• Applicant: Mam International AG
• Product Code: KKO · Dental
• Decision Date: Jun 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5550
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The MAM Twister Teether was developed for the needs of babies who are having their first teeths. It is designed to offer optimum comfort and safety for the baby and offers all the soothing textures and cooling comfort in order to case babies teething pain.

Device Story

MAM Twister is a fluid-filled teething ring designed to provide cooling comfort and soothing textures to infants during teething. Device functions as a passive oral aid; no electronic components, sensors, or software. Used by infants under caregiver supervision to alleviate teething pain. Safety and performance are established through compliance with toy safety standards, including bite tests, flammability, and chemical safety (lead and phthalate bans).

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including bite tests, flammability testing, small parts requirements, and chemical safety analysis (lead and phthalate content) per ASTM and CFR standards.

Technological Characteristics

Fluid-filled teething ring. Materials comply with ASTM F963, 16 CFR 1303 (lead paint), CPSIA Sec. 101 (lead substrate), and CPSIA Sec. 108 (phthalates). Meets USP <61> for bacteriological cleanliness. Tested for mechanical hazards per 16 CFR 1500 and ASTM F963 (sections 8.6-8.10). Flammability compliant with 16 CFR 1500.44. Small parts compliant with 16 CFR 1501. Bite test compliant with 16 CFR 1500.52(c).

Indications for Use

Indicated for babies experiencing teething pain during the eruption of their first teeth.

Regulatory Classification

Identification

A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process.

Special Controls

*Classification.* Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.(2) Class II (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Predicate Devices

• WATER FILLED TEETHER, ROYAL INDUSTRIES (THAILAND) PUBLIC CO. LTD. (K052105)

Submission Summary (Full Text)

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JUN 2 3 2010

# Section C 510(k) Summary (21 CFR 807.92)

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The assigned 510(k) number is: K092781

(a) (1) The summary contains on the first page, preferably on your letterhead paper, the submitters name, address, phone and fax numbers, name of contact person, and date the summary was prepared:

Submitter's name: Submitter' s address:

Contact Name:

Phone No .: Fax No.:

Facility Registration No .: Owner Operator No .:

MAM International AG Wilenstraße 17 8832 Wollerau, Schwyz Switzerland

Markus Schoell

0043-1-49141-715 0043-1-49141-719

3003296982 9054867

Date of Summary:

23.07.2009

#### (a) (2) The name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name if known:

| Device Name/ Trade Name:: | MAM Twister |
|---------------------------|----------------------------|
| Classification Name: | Fluid-Filled Teething Ring |
| Device Classification: | II |
| Regulation Number: | 872.5550 |
| Panel: | Dental |
| Product Code : | KKO |

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Image /page/1/Picture/0 description: The image is a square icon with rounded corners. The background of the icon is white. In the center of the icon, there is the text "MAM" in bold, black letters. The letters are outlined in black, giving them a slightly raised appearance.

### (a) (3) An identification of the legally marked device to which your firm is claiming substantial equivalence:

Class II Fluid-Filled Teething Ring (Teether with waterfilled part) that that meets requirements of USP <61>. ASTM F963 section 4.3.6.1 & 4.3.6.3. 16 CFR 1303 - Ban of lead-containing paint (< 90 ppm), CPSIA Sec.101: general lead ban - lead in substrate (< 100 ppm). 16 CFR 1500 - Mechanical Hazards, ASTM F963 - toy standard, 16 CFR 1500.44 - Flammability of solids, 16CFR1501 - Small part requirement, CPSIA Sec.108 & CA Bill 1108 - Ban on phthalates (DEFIP, DBP, DINP, DIDP, DIDP, DnOP < 0,1%), 16 CFR 1500.52(c) - Bite test, EN 71-1, EN 71-3 & EN 71-9

#### Predicate device:

WATER FILLED TEETHER, ROYAL INDUSTRIES (THAILAND) PUBLIC CO. LTD. K052105

#### (a) (4) A description of the device:

Class II Fluid-Filled Teething Ring (Teether with waterfilled part) that that meets requirements of USP <61>, ASTM F963 section 4.3.6.1 & 4.3.6.3, 16 CFR 1303 - Ban of lead-containing paint (< 90 ppm), CPSIA Sec.101: general lead ban - lead in substrate (< 100 ppm), 16 CFR 1500 - Mechanical Hazards, ASTM F963 - toy standard, 16 CFR 1500.44 - Flammability of solids, 16CFR1501 - Small part requirement, CPS1A Sec.108 & CA Bill 1108 - Ban on phthalates (DEHP, DBP, DINP, DIDP, DIDP, DIOP < 0,1%), 16 CFR 1500.52(c) - Bite test, EN 71-1, EN 71-3 & EN 71-9

## (a) (5) The Summary describes the intended use of the device

Device Intended Use: The MAM Twister Teether was developed for the needs of babies who are having their first tecths. It is designed to offer optimum comfort and safety for the baby and offers all the soothing textures and cooling comfort in order to case babies teething pain.

#### (a) (6) A Summary of the technological characteristics of new device compared to the predicate device:

The MAM Twister is summarized with the following technological characteristics compared to ASTM or equivalent standard

| Characteristics | Standard | Device performance |
|--------------------------------------|--------------------------------------|--------------------|
| Bacteriological | USP <61> / ASTM F963 section 4.3.6.1 | Meets |
| Cleanliness of products used in toys | ASTM F963 section 4.3.6.3 | Meets |
| Ban of lead-containing paint | 16 CFR 1303 | Meets (< 90 ppm) |
| General lead ban - lead in substrate | CPSIA Sec. 101 | Meets (< 100 ppm) |
| Mechanical Hazards | 16 CFR 1500 | Meets |
| Mechanical Hazards | ASTM F963 section 8.6 - 8.10 | Meets |
| Flammability of solids | 16 CFR 1500.44 | Meets |
| Dimension - Small part requirement | 16CFR1501 | Meets |
| Ban on phthalates | CPSIA Sec.108 & CA Bill 1108 | Meets |
| Mechanical Hazards - Bite Test | 16 CFR 1500.52(c) | Meets |
| Safety of toys | EN 71-1, EN 71-3 & EN 71-9 | Meets |

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Image /page/2/Picture/0 description: The image is a logo for MAM, a company that makes baby products. The logo is a square with rounded corners, and the letters "MAM" are written in the center in a bold, sans-serif font. The letters are outlined in black, and the inside of the letters is white. The background of the square is also white.

#### (b) (1) A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence:

The MAM Twister Teether meets requirements of USP <61>, ASTM F963 section 4.3.6.1 & CFR 1303 - Ban of lead-containing paint (< 90 ppm), CPSIA Sec. 101: general lead ban - lead in substrate (< 100 ppm), 16 CFR 1500 - Mechanical Hazards, ASTM F963 - toy standard, 16 CFR 1500.44 - Flammability of solids, 16CFR1501 - Small part requirement, CPSIA Sec.108 & CA Bill 1108 - Ban on phthalates (DEHP, DBP. BBP, DINP, DIDP, DnOP < 0,1%), 16 CFR 1500.52(c) - Bite test, EN 71-1, EN 71-3 & EN 71-9

#### (b) (2) A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence:

Clinical data is not needed for Fluid Filled Teethers for devices cleared by the 510 (k) process.

#### (b) (3) The conclusion drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a);

It can be concluded that the MAM Twister Teether meet all above mentioned tests so FDA 510(k) approval shall be issued for this product

#### (c) (1) Additional questions which was answered by MAM regarding 510(k) pre-market notification of The MAM Twister dossier: K092781

Please find additional information in the general document "MAM Twister K092781 additional question FDA summary"

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

# JUN 2 3 2010

MAM International AG C/O Mr. Michael Tedesco MAM USA Corporation Corporate Park Drive 106 White Plains, New York 10604

Re: K092781 Trade/Device Name: MAM Twister Regulation Number: 21 CFR 872.5550 Regulation Name: Teething Ring Regulatory Class: II Product Code: KKO Dated: June 16, 2010 Received: June 17, 2010

Dear Mr. Tedesco:

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.

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# Page 2- Mr. Tedesco

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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Susan Purre

Anthony D. Watson, BS, MS, MBA Director

Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE FORM

## INDICATIONS FOR USE

510(K) Number (if known): K092781

Device Name: MAM Twister

Indications for Use:

The MAM Twister Teether was developed for the needs of babies who are having their first teeths. It is designed to offer optimum comfort and safety for the baby and offers all the soothing textures and cooling comfort in order to ease babies teething pain.

Prescription Use

AND/OR

(Part 21 CFR 801 Subpart D)

(21 CRF 801 Subpart C)

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muliy for MSA

n Sian-Off Division of Anesthesiology, General Hospital . Infection Control, Dental Devices

510(k) Number