(48 days)
Prepare™ Administration Set is intended for the administration of various medical solutions from an IV container to the patient's access catheter and is used only with Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps. Intended for intravenous, intra-arterial, subcutaneous, epidural, and subarachnoid administration.
Prepare™ Administration Set is indicated for use in acute and alternate site settings. Alternate sites include, but are not limited to, infusion clinics, nursing homes, and home healthcare.
Prepare™ Administration Set is designed for use with Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps. The device provides the interface with the pump and a sterile fluid path from an infusion fluid container to a patient's access catheter.
Here's a breakdown of the acceptance criteria and study information for the Prepare™ Administration Set based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from comparison to predicate) | Reported Device Performance (Prepare™ Administration Set) |
|---|---|---|
| Physical/Technical Characteristics | Comparable to CADD® Administration Set (materials, size, interface w/ pumps) | Comparable |
| Accuracy of Delivery | Substantially equivalent to CADD® Administration Set | Substantially equivalent |
| Volume Delivered per Pump Cycle | Substantially equivalent to CADD® Administration Set | Substantially equivalent |
| Fit to Pump | Substantially equivalent to CADD® Administration Set | Substantially equivalent |
| Biocompatibility | Non-irritating, non-cytotoxic, non-toxic, non-hemolytic, non-sensitizing (based on ISO-10993-1) | Certified as non-irritating, non-cytotoxic, non-toxic, non-hemolytic, and non-sensitizing |
| Sterility | Sterilized by ethylene oxide gas in a validated process | Sterilized by ethylene oxide gas in a validated process |
Study Proving Device Meets Acceptance Criteria:
The study conducted was a bench test comparison between the Prepare™ Administration Set and the predicate device, the CADD® Administration Set, along with biocompatibility and sterility testing.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for the bench tests. It only states that "the device and the predicate were subjected to various bench tests."
- Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing by APPRO Healthcare, Inc. (the manufacturer). This would be prospective data generation for premarket submission. No country of origin for the data is mentioned other than the manufacturer being in the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This type of device (administration set) does not typically involve expert review for its performance evaluation in the way, for instance, a diagnostic image analysis AI would. The "ground truth" for the performance criteria (e.g., accuracy of delivery) would be established by calibrated measurement instruments and engineering specifications.
4. Adjudication Method for the Test Set
- Not Applicable. As no expert review or human interpretation was involved for determining the device's functional performance during bench testing, no adjudication method was necessary or performed.
5. 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
- No. An MRMC study is not relevant for this type of medical device (an administration set). These studies are typically conducted for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance to measure performance improvement.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a passive administration set and does not involve an algorithm or AI. Its function is mechanical/fluidic, not computational.
7. The Type of Ground Truth Used
- The ground truth for the performance criteria (accuracy of delivery, volume delivered, fit to pump) would have been objective measurements obtained from calibrated testing equipment and engineering specifications, compared against the predicate device's established performance.
- For biocompatibility, the ground truth was based on standardized biological assays as recommended by ISO-10993-1.
- For sterility, the ground truth was based on validated sterilization process criteria (e.g., Sterility Assurance Level - SAL).
8. The Sample Size for the Training Set
- Not Applicable. This device does not use machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for this type of device, this question is irrelevant.
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DEC 3 0 2002
510(k) SUMMARY
| Date: | November 6, 2002 |
|---|---|
| Manufacturing Facility: | APPRO Healthcare, Inc.847 Main StreetBuffalo, NY 14203 |
| Telephone: | (716) 855-1068 |
| Contact Person: | John R. SemlerVice President, RD&EExtension 309Email: jrsemler@approhealthcare.com |
| Device Trade Name: | Prepare™ Administration Set |
| Device Common Name: | Administration Set |
| Classification Name: | Intravascular Administration Set |
| Regulatory Reference: | FPA |
| Predicate Device | CADD® Administration Set |
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Description:
Prepare™ Administration Set is designed for use with Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps. The device provides the interface with the pump and a sterile fluid path from an infusion fluid container to a patient's access catheter.
Intended Use / Indications for Use:
Prepare™ Administration Set is intended for the administration of various medical solutions from a fluid container to the patient's access catheter, and is used only with Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps. Intended for intravenous, intraarterial, subcutaneous, epidural, and subarachnoid administration.
Prepare™ Administration Set is indicated for use in acute and alternate site care settings. Alternate site care includes, but is not limited to, infusion clinics, nursing homes, and home healthcare.
Physical/Technical Comparison
Prepare™ Administration Set can be used in place of CADD® Administration Set. Physical and technical characteristics, including materials used in construction, size, intended use and ability to interface with specified CADD® pumps, are comparable.
Performance Summary:
The device and the predicate were subjected to various bench tests to demonstrate comparable performance characteristics. Prepare™ Administration Set's accuracy of delivery, volume delivered per pump cycle, and fit to pump are substantially equivalent to the CADD® Administration Set.
Biocompatibility Testing:
Prepare™ Administration Set device was subjected to biocompatibility testing as recommended by ISO-10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. The device is certified as non-irritating, non-cytotoxic, non-toxic, non-hemolytic, and non-sensitizing.
Sterility:
Prepare™ Administration Set is sterilized by ethylene oxide gas in a validated sterilization process.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of a human figure in profile, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
·Mr. John R. Semler APPRO Healthcare, Incorporation 847 Main Street Buffalo, New York 14203
Re: K023769
Trade/Device Name: Prepare™ Administration Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: November 6, 2002 Received: November 12, 2002
Dear Mr. Semler:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Semler
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4618. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (30 .) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timbthy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 1 of 1
102 7 510(k) Number, if known: Not yet assigned
Prepare™ Administration Set Device Name:
Indications for Use:
Prepare™ Administration Set is intended for the administration of various medical solutions from an IV container to the patient's access catheter and is used only with Deltec CADD®-1, CADD®-Plus, and CADD®-PCA pumps. Intended for intravenous, intra-arterial, subcutaneous, epidural, and subarachnoid administration.
Prepare™ Administration Set is indicated for use in acute and alternate site settings. Alternate sites include, but are not limited to, infusion clinics, nursing homes, and home healthcare.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-the-Counter Use (Per 21CFR 801.109)
William M. Dundle Kerr
Katherine Vincent
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:_
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.