STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291

K981905 · Acu-Pak · FOZ · Aug 18, 1998 · General Hospital

Device Facts

• Record ID: K981905
• Device Name: STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291
• Applicant: Acu-Pak
• Product Code: FOZ · General Hospital
• Decision Date: Aug 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Indications for Use

ACU-PAK Sterile Saline Solution 0.9% / Sterile Water are used in health care facilities for the irrigation of general medical devices. It is used as a lubricant for suction catheters.

Device Story

Device consists of 100ml of 0.9% sterile saline solution or sterile water in a 100cc polyethylene wide-mouthed bottle; closure is a 38/400 polypropylene cap with F-217 liner and tamper-evident band. Used in healthcare facilities for irrigation of medical devices and lubrication of suction catheters. Product is non-injectable. Device is a sterile, single-use liquid supply.

Clinical Evidence

No clinical data; bench testing only. Substantial equivalence is based on identical materials, design, and manufacturing processes to legally marketed predicate devices.

Technological Characteristics

100ml 0.9% saline or sterile water; 100cc polyethylene bottle; 38/400 polypropylene cap with F-217 liner; tamper-evident shrink band. Sterile, non-injectable.

Indications for Use

Indicated for use in health care facilities for the irrigation of general medical devices and as a lubricant for suction catheters. Not for injection.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• Saline Solution 0.9% (K922033)
• Sterile Water (K933526)
• Sterile Saline Solution (KA05950)
• Sterile Water (KF11560)
• 0.9% Isotonic Saline, Sterile (K95442)
• Sterile Water (K95442)

Submission Summary (Full Text)

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## AUG 1 8 1998

SECTION E:

## 510(k) SUMMARY

- ACU-PAK, Inc. Submitted by: 1. 2 Perimeter Road East Londonderry, NH 03053 Phone [phone] [phone] Fax
Contact: Carol Thompson Regulatory Manager

05/29/98 Preparation Date:

- Sterile Saline Solution 0.9% and Sterile Water 2. Device Name:
- Sterile Saline, Sterile Water Common Name:

Catheter and Tip, Suction Classification Name:

- K922033 Saline Solution 0.9% 3. Predicate devices: K933526 - Sterile Water Trinity Laboratories Salisbury, MD 21801
KA05950 - Sterile Saline Solution KF11560 - Sterile Water Superior Plastics Products Cumberland, RI 02864 (company purchased by) Kendall Healthcare Products Company Mansfield, MA 02048

K95442 - 0.9% Isotonic Saline, Sterile Sterile Water MedCare Medical Group East Swanzey, NH 03446

2 Perimeter Road, East

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

ACU-PAK, Inc. 510 (k) Application Sterile Saline Solution 0.9% / Sterile Water

## Device Description: 4.

ACU-PAK Sterile Saline Solution 0.9% and Sterile Water are used for the irrigation of medical devices. The device consists of 100ml of Saline Solution at a concentration of 0.9% or Water contained within a 100cc polyethylene wide mouthed bottle. The closure is a 38/400 white polypropylene cap fitted with an F 217 liner. A printed tamper-evident band is placed over the top of the bottle. Each bottle contains a product label displaying a lot code and expiration date.

- Intended use of the device: న్.
ACU-PAK Sterile Saline Solution 0.9% and Sterile Water are used for the irrigation of medical devices. These products are not for injection.

- Technological characteristics: 6.
ACU-PAK Sterile Saline Solution 0.9% and Sterile Water are identical to the predicate devices. All of the predicate devices contain 100 ml of 0.9% Saline or Water packaged in a 100ml polypropylene bottle. The closures are 38/400 caps with F-217 liners. All of the predicate devices have a tamper-evident shrink band.

- 7. Additional Equivalency information:
ACU-PAK, Inc. is the contract manufacturer for all of the predicate devices. Manufacture of these products has been ongoing for the past 9 years. ACU-PAK Sterile Saline Solution 0.9% and Sterile Water is identical to predicate devices.

Carol Thompson

Carol Thompson Regulatory manager

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three arms or lines extending upwards.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 1998

Ms. Carol Thompson Regulatory Manager ACU-PAK, Incorporated 2 Perimeter Road East Londonderry, New Hampshire 03053

Re : K981905 Sterile Saline Solution 0.9% Catalog No. Trade Name: 10290, Sterile Water - Catalog No. 10291 Requlatory Class: II Product Code: FOZ Dated: May 29, 1998 Received: June 1, 1998

Dear Ms. Thompson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Thompson

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.qov/cdrh/dsma/dsmamain.html".

Sincerely yours, - -

S. Dutman for

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation ..... Center for Devices and Radiological Health

Enclosure ...

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| CONTENT OF A 510(k) | Page 12 |
|---------------------|---------|
|---------------------|---------|

Ver/ 3 - 4/24/96

| Applicant: | ACU-PAK, Inc. |
|---------------------------|----------------------------------------------|
| 510(k) Number (if known): | K981905 |
| Device Name: | Sterile Saline Solution 0.9% / Sterile Water |
| Indications For Use: | |

ACU-PAK Sterile Saline Solution 0.9% / Sterile Water are
used in health care facilities for the irrigation of
general medical devices. It is used as a lubricant for
suction catheters.

(Division Sign-Off)

Division of Dental, Infection Control,
and General Hospital Devices

| 510(k) Number | K981905 |
|---------------|---------|
|---------------|---------|

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div> <span>✓</span> <span>OR Over-The-Counter</span> </div> |
|------------------|--------------------------------------------------------------|
|------------------|--------------------------------------------------------------|

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

და სამხრეთ სამხარდონის სახლეობა სადგურების სახელმწიფო სახლების მონაცემებით მონაცემებით მონაცემები იყო სახელწოდების მონაცემებით მონაცემებით მო

What is the Relationship Between Design Controls and 510(k)

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