(372 days)
The AP Harness is to be used as a safety line between a patient and a medical machine which are connected by a medical line, (ie IV tubing, oxygen tubing, enteral tubing, etc. ). This device would be used when the patient or caregiver cannot maintain an adequate level of safety for an important catheter or other medical line.
The A.P. Harness System facilitates increased safety and comfort of the active child or other patient while he/she is hooked-up to TPN, IV, enteral tube feed or other medical lines. This safety is accomplished by providing the maximum distance between the child and pump stand, determined by the length in the medical lines. This allows the child better access to his/her environment. The harness also limits kinking and subsequent occlusion in the medical lines. This frees the child from interruptions in play, while the caregiver searches for the location of an occlusion in the medical lines. Another benefit is increased safety and lowered stress for the caregiver. This means the supervision of the medical lines is done less intensively, and therefore the caregiver's attention can be directed to the child as a whole person and not just as a patient.
This system is comprised of a harness, a tether strap, an anchor strap, and a zipper sleeve. It is equipped with buckles that are small, low profile, strong, and secure. The shoulder straps are moveable along the chest strap; this facilitates infinite adjustability for a growing patient or for multiple patient use. The chest strap is worn directly underneath the axillas (armpits), which facilitates unhindered diaper changes and avoids soiling. The harness's location high on the chest puts the minimum amount of restriction on the respiratory system, as well as keeping access for common medical evaluations and nursing procedures. The chest strap is made of soft tubular webbing, which contours to the patients chest, preventing abrasion and pinching.
This document is a 510(k) summary for the AP Harness, a safety harness for medical lines, and does not include information about acceptance criteria or a study proving the device meets those criteria. The provided text is a regulatory submission for premarket notification to the FDA, demonstrating substantial equivalence to a predicate device, not a performance study.
Therefore, I cannot provide the requested information. The document focuses on:
- Device Description: What the AP Harness is and how it works.
- Intended Use: The purpose and application of the device.
- Regulatory Classification: Its classification details and a determination of substantial equivalence by the FDA.
- Contact Information: For the applicant and FDA.
There is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method for a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- A standalone (algorithm-only) performance study.
- The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
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Image /page/0/Picture/2 description: The image shows the logo and contact information for PARAWORKS ENTERPRISE LTD. The logo features a stylized graphic with the company name written in cursive. The contact information includes the phone number 604 871 0040 and the address #1-179 West 17th Avenue, Vancouver, British Columbia, Canada, V5Y 1Z7.
510(K) SUMMARY
Feb 28, 1999
510(k) Number: K981860 Proprietary Name: AP Harness Common Name: Safety Harness for Medical lines Classification Name: Set, tubing and Support Classification Number: BZO Regulatory Class: II Contact person: Michael Campbell, president, PARAWORKS ENTERPRISE LTD. Substantially Equivalent to: Baxter's SiteLock™ Epidural Catheter Securement Device
Description:
The A.P. Harness System facilitates increased safety and comfort of the active child or other patient while he/she is hooked-up to TPN, IV, enteral tube feed or other medical lines. This safety is accomplished by providing the maximum distance between the child and pump stand, determined by the length in the medical lines. This allows the child better access to his/her environment. The harness also limits kinking and subsequent occlusion in the medical lines. This frees the child from interruptions in play, while the caregiver searches for the location of an occlusion in the medical lines. Another benefit is increased safety and lowered stress for the caregiver. This means the supervision of the medical lines is done less intensively, and therefore the caregiver's attention can be directed to the child as a whole person and not just as a patient.
This system is comprised of a harness, a tether strap, an anchor strap, and a zipper sleeve. It is equipped with buckles that are small, low profile, strong, and secure. The shoulder straps are moveable along the chest strap; this facilitates infinite adjustability for a growing patient or for multiple patient use. The chest strap is worn directly underneath the axillas (armpits), which facilitates unhindered diaper changes and avoids soiling. The harness's location high on the chest puts the minimum amount of restriction on the respiratory system, as well as keeping access for common medical evaluations and nursing procedures. The chest strap is made of soft tubular webbing, which contours to the patients chest, preventing abrasion and pinching.
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Intended Use of the Device:
The AP Harness is to be used as a safety line between a patient and a medical machine whom are connected by a medical line, (ie IV tubing, oxygen tubing, enteral tubing, etc. ). This device would be used when the patient or caregiver cannot maintain an adequate level of safety for a important catheter or other medical line.
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Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol consisting of three wavy lines that form the silhouette of a human head in profile. The lines are thick and bold, creating a sense of movement and flow.
3 1999 JUN
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael C. Campbell President Paraworks Enterprise Limited #1-179 West 17th Avenue Vancouver, British Columbia Canada, V5Y IZ7
- Re: K981860 Trade Name: AP Harness Requlatory Class: I Product Code: KMK February 28, 1999 Dated: Received: March 11, 1999
Dear Mr. Campbell:
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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Campbell
this response to your premarket notification Please note: Prease note. Enro rebponso ov Jobligation you might have under Bubmisblom as through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your tial equivalence of your device to a legally marketed predicate device results in a classification for your markets predication wour device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (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 Orice of Compriand as (cranding by reference to che regulation chercica, "Missianalisy") 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.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Applicant: PARAWORKS ENTERPRISE LTD. 510(k) Number: K981860 Device Name: AP Harness
Indications For Use:
The AP Harness is to be used as a safety line between a patient and a medical machine which are connected by a medical line, (ie IV tubing, oxygen tubing, enteral tubing, etc. ). This device would be used when the patient or caregiver cannot maintain an adequate level of safety for an important catheter or other medical line.
(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 use ✓ |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Numbe
§ 880.5210 Intravascular catheter securement device.
(a)
Identification. An intravascular catheter securement device is a device with an adhesive backing that is placed over a needle or catheter and is used to keep the hub of the needle or the catheter flat and securely anchored to the skin.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.