HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)

K101547 · Henke-Sass, Wolf GmbH · FMF · Nov 22, 2010 · General Hospital

Device Facts

• Record ID: K101547
• Device Name: HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)
• Applicant: Henke-Sass, Wolf GmbH
• Product Code: FMF · General Hospital
• Decision Date: Nov 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HSW NORM-JECT®- syringes are intended to be used to inject into, or withdraw fluids from the body. The 1 ml- syringe with a purple plunger, labeled with is exclusively produced for for use with BOTOX® Cosmetic BOTOX® (onabotulinumtoxinA).

Device Story

Piston syringe used for fluid injection or withdrawal; 1 ml version features purple plunger specifically for BOTOX® Cosmetic administration. Device operates via manual plunger displacement within barrel; Luer taper fitting for needle attachment. Used in clinical settings by healthcare professionals. Output is fluid delivery or aspiration. Benefits include precise dosing for specific cosmetic applications.

Clinical Evidence

Bench testing only. Compliance with ISO 10993 series (biocompatibility, hemocompatibility, cytotoxicity, sensitization, irritation, acute systemic toxicity, EtO residuals), ISO 7886-1 (sterile hypodermic syringes), ISO 594-1 (Luer taper), ISO 11135-1 (sterilization), and ISO 11607 (packaging).

Technological Characteristics

Piston syringe with purple-colored plunger. Materials meet ISO 10993 biocompatibility standards. Features 6% Luer taper per ISO 594-1. Sterilized via Ethylene Oxide (EtO) per ISO 11135-1. Manual operation.

Indications for Use

Indicated for injection into or withdrawal of fluids from the body. The 1 ml syringe with purple plunger is indicated exclusively for use with BOTOX® Cosmetic (onabotulinumtoxinA).

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Henke-Sass, Wolf piston syringes (K821537)
• B.Braun piston syringes (K063280)

Submission Summary (Full Text)

{0}------------------------------------------------

Attachment 13.2 - Replaces original Section 15

Section 15 - Summary of Safety & Effectiveness

Henke Sass Wolf GmbH 510(k) Submission

NOV 22 2010

1

Submitter:

Henke-Sass, Wolf GmbH Keltenstrasse 1 78532 Tuttlingen Germany

Manufacturing site:

ALMO Erzeugnisse Erwin Busch GmbH Grosse Allee 84 34454 Bad Arolsen Germany

Submission Correspondent / Contact Person:

Lyle Howard Corporation / Lynette Howard 106 East 5th Avenue Mount Dora, FL 32757

Premarket Notification information required by 21 CFR Part 807, subpart E is as follows:

# 1. GENERAL INFORMATION

| Classification Name: | piston syringe |
|---------------------------------------------------------|-----------------------------------------|
| Common usual name: | piston syringe |
| Proprietary name: | sterile single use syringe (NORM-JECT®) |
| Establishment Registration Number (submitter): | 8010418 |
| Establishment Registration Number (manufacturing Site): | 8010674 |

Classification: Class II, FMF, Panel: 80, Regulation Number: 21 CFR 880.5860

The purpose of this request is for marketing clearance of Henke-Sass, Wolf piston syringe because we have added a new purple-colored plunger for a new version of the syringe.

The piston syringes covered by this submission will have the same performance as already marketed devices. The only difference will be the coloring of the plunger in adding a master batch to the original material. The safety and effectiveness will be comparable to the predicate devices.

{1}------------------------------------------------

Indications for Use:

"The HSW NORM-JECT®- syringes are intended to be used to inject into, or withdraw fluids from the body. The 1 ml- syringe with a purple plunger, labeled with is exclusively produced for for use with BOTOX® Cosmetic BOTOX® (onabotulinumtoxinA)."

#### SUBSTANTIAL EQUIVALENCE:

The Henke-Sass, Wolf piston syringe is substantially equivalent to the Henke-Sass, Wolf piston syringes under 510(k)# (K821537) and the B.Braun piston syringes under 510(k)# (K063280). (The manufacturing site of B.Braun is also ALMO, Establishment Registration Number: 8010674.)

### SAFETY AND EFFECTIVENESS INFORMATION:

The Henke-Sass, Wolf piston syringe is well recognized as being safe and effective for the declared intended use. The Henke-Sass. Wolf piston syringe does have the identical operating principles and the same intended uses than the predicate devices such as Henke-Sass, Wolf piston syringes under 510(k) # K821537 and B.Braun piston syringes under 510(k) # (K063280) already in commercial distribution.

Testing conducted to assure safety and effectiveness includes but is not limited to:

- Biological evaluation of Medical Devices: .
ISO 10993-1:2009: Biological Evaluation for Medical Devices:

ISO 10993-4:2002; Hemocompatibility

ISO 10993-5:2009; Cytotoxicity

ISO 10993-10:2002; Sensitization

ISO 10993-10:2002; Irritation or Intracutaneous Reactivity

ISO 10993-11:2006; Acute Systemic Toxicity

- ISO 7886-1: 1993; Sterile hypodermic syringes for single use ●
- ISO 594-1:1986; Conical fittings with 6% (Luer) taper for Syringes, Needles and other ● Medical Equipment, general requirements
- ISO 10993-7:2008: Biological Evaluation for Medical Devices; EtO- Residuals ●
- ISO 11135-1:2007: Sterilization Validation (EtO) ●

{2}------------------------------------------------

- ISO 11607-1:2006; Packaging for terminally sterilized medical devices -- Part 1: . Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2:2006; Packaging for terminally sterilized medical devices -- Part 2: . Validation requirements for forming, sealing and assembly processes

## Summary of Performance Data

The performance data presented in this safety & effectiveness summary and the attachments presented with the 510(k) submission demonstrates that this device is substantially equivalent to the predicate devices.

{3}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle or bird symbol with three curved lines representing its wings or body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird symbol.

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

Henke-Sass Wolf, GmbH C/O Ms. Lynette Howard Lyle Howard Corporation 106 East 5" Avenue Mount Dora, Florida 32757

NOV 2 2 2010

Re: K101547

Trade/Device Name: Piston Syringe (Norm -Jet) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: November 3, 2010 Received: November 4, 2010

Dear Ms. Howard:

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.

{4}------------------------------------------------

### Page 2- Ms. Howard

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/ucm1115809.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 offer number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Section 6 - Indications for Use Statement - Revised

HSW- 510(k) for piston syringes

Image /page/5/Picture/3 description: The image shows a logo with two distinct parts. On the left, there is a white triangle inside of a white circle, all set against a black square. To the right, also set against a black square, is the text "HENKE SASS WOLF" stacked vertically in white lettering. The text is in a sans-serif font and appears to be bolded.

Indications for Use .

NOV 2 2 2010

510(k) Number (if known): K101547

Device Name: piston syringe

Indications for Use:

"The HSW NORM-JECT®- syringes are intended to be used to inject into, or withdraw fluids from the body. The 1 ml- syringe with a purple plunger, labeled with BOTOX® is exclusively produced for use with BOTOX® Cosmetic (onabotulinumtoxinA)."

Prescription use: X (Part 21 CFR 801 subpart D) And /or

Over-the counter-use: ---(Part 21 CFR 801 subpart C)

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

Suon Rumer fr. Pekl Chappine

(Division Sign-Off) Division of Anesthesioiogy, General Hospital Infection Control, Dental Devices

510(k) Number: