(78 days)
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.
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.
The provided text is a 510(k) summary for a medical device: ACU-PAK Sterile Saline Solution 0.9% and Sterile Water. This document is a premarket notification for a Class II medical device, indicating that the manufacturer believes it is substantially equivalent to legally marketed predicate devices.
The information provided does not include a study that proves the device meets specific acceptance criteria in the way described in your request (e.g., performance metrics, statistical analysis, or clinical trial results). This is because the 510(k) process for devices like sterile saline or water for irrigation typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical performance studies with specific acceptance criteria that need to be met by the new device itself.
Instead, the submission focuses on demonstrating that the ACU-PAK product has the same intended use and technological characteristics as predicate devices. The "performance" in this context refers to its similarity to already approved products.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from a traditional performance study, nor can I provide information about sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance. These types of studies are typically required for more novel or higher-risk devices where substantial equivalence cannot be solely established through technological comparison.
However, I can extract the relevant information from the provided text demonstrating how the device meets the criteria for substantial equivalence based on its comparison to predicate devices.
Summary of Acceptance Criteria and Device Performance (as per 510(k) submission for Substantial Equivalence):
This 510(k) submission relies on demonstrating substantial equivalence to predicate devices rather than meeting new, unique performance criteria through a standalone study. The "acceptance criteria" here are the characteristics and intended use that must match or be equivalent to already approved devices.
| Acceptance Criteria (based on Predicate Device Equivalence) | Reported Device Performance (ACU-PAK Product) |
|---|---|
| Intended Use: Irrigation of medical devices (Not for injection) | Intended Use: Irrigation of medical devices (Not for injection) |
| Composition: 0.9% Saline Solution or Water | Composition: 0.9% Saline Solution or Water |
| Volume: 100ml | Volume: 100ml |
| Container: Polyethylene wide-mouthed bottle (100cc) | Container: Polyethylene wide-mouthed bottle (100cc) |
| Closure: 38/400 white polypropylene cap with F 217 liner | Closure: 38/400 white polypropylene cap with F 217 liner |
| Tamper-Evident Feature: Printed tamper-evident band | Tamper-Evident Feature: Printed tamper-evident band |
| Labeling: Product label displaying lot code and expiration date | Labeling: Product label displaying lot code and expiration date |
| Manufacturing: Same contract manufacturer for over 9 years | Manufacturing: Same contract manufacturer (ACU-PAK, Inc.) for predicate devices for over 9 years |
Information Regarding Study and Ground Truth (for Substantial Equivalence):
-
Sample size used for the test set and the data provenance: Not applicable. This 510(k) relies on a comparison of device characteristics to predicate devices, not a test set of data. The "data provenance" is the existence of legally marketed predicate devices.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set is not established in this type of submission. The "ground truth" for substantial equivalence is that the predicate devices are legally marketed and safe/effective. The FDA regulatory reviewers eventually make the determination of substantial equivalence.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no test set or adjudication process as typically understood in performance studies.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a sterile solution, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a sterile solution, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices as determined by their prior clearance by the FDA. The new device demonstrates substantial equivalence to these predicate devices. The manufacturer states, "ACU-PAK Sterile Saline Solution 0.9% and Sterile Water is identical to predicate devices."
-
The sample size for the training set: Not applicable. No training set is used for this type of device submission.
-
How the ground truth for the training set was established: Not applicable. No training set is used.
Conclusion:
The ACU-PAK Sterile Saline Solution 0.9% and Sterile Water device meets its "acceptance criteria" by demonstrating that it is substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, and manufacturing processes. The "study" proving this is the 510(k) submission itself, which provides a detailed comparison of the new device to the predicate devices. The FDA's clearance (letter dated AUG 18 1998) confirms this finding of substantial equivalence.
{0}------------------------------------------------
AUG 1 8 1998
SECTION E:
510(k) SUMMARY
- ACU-PAK, Inc. Submitted by: 1. 2 Perimeter Road East Londonderry, NH 03053 Phone (603) 668-7688 (603) 668-1102 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. -
- 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.
- Additional Equivalency information:
Carol Thompson
Carol Thompson Regulatory manager
{2}------------------------------------------------
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
{3}------------------------------------------------
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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 ...
{4}------------------------------------------------
| 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 | ✓ OR Over-The-Counter |
|---|---|
| ------------------ | -------------------------------------------------------------- |
(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)
. …
realings sour = r
Page Contents
지원
§ 880.5200 Intravascular catheter.
(a)
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.(b)
Classification. Class II (performance standards).