The indication for use is reconstitution and transfer of drug solutions from one container to another while minimizing exposure to potentially hazardous drugs aerosols and spills that can occur during the reconstitution, administration and disposal process.

Device Description

The single lumen docking station of the Protector is fitted to the drug vial for the parenteral drug. The Injector is connected to the Protector and liquid transfer takes place through tightly fitting elastomeric double membranes to minimize leakage during reconstitution, administration and disposal processes. The Protector equilibrates the pressure difference which occurs when fluid or air is added to, or removed from the drug vial.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called "PhaSeal® - A Closed System Drug Transfer Device for Preparation and Administration of Parenteral Drugs" and its components (Protector P14, P21, P28, and P50). However, the document does not contain acceptance criteria, a specific study proving the device meets those criteria, or the detailed information requested in your prompt (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details).

Instead, the document details a substantial equivalence comparison to predicate devices for regulatory clearance. The core of the submission is to demonstrate that the new devices (Modified P14, P21, P28, P50) are functionally equivalent to previously cleared devices (Predicate P14, P21, P50 from K001368).

The relevant sections are "5. Technological characteristics, comparison to predicate device" and "6. Discussion of performance testing."

Here's a breakdown of what can be extracted and what information is missing based on your prompt:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria or a direct measurement of "device performance" in terms of specific metrics like leakage rates or contamination levels. Instead, it relies on demonstrating equivalence to predicate devices, which are presumed to meet established safety and effectiveness standards.

The closest we can get to "performance" is the comparison table which shows direct equivalence in intended use, material, spike type (with one exception for P28), drug vial size, expansion chamber, and sterilization method.

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Comparison to Predicate)
Intended Use: Drug Vial Adapter for closed reconstitution of parenteral drugs.	Met: Identical
Material: Polypropylene	Met: Identical
Spike: Stainless steel	Met for P14, P21, P50: Identical
Spike: Stainless steel	Not met for P28 (Plastic): Different, but presumably deemed acceptable through "performance testing" referenced generally.
Drug vial size: Ø 13 mm (P14), Ø 20 mm (P21, P50), Ø 28 mm (P28)	Met: Identical
Expansion chamber: 20 ml (P14, P21), 50 ml (P28, P50)	Met: Identical
Sterilization method: EtO	Met: Identical
Overall Safety and Effectiveness: No new concerns compared to predicate.	"The Protectors have been tested and found in compliance with applicable requirements and standards specifications."

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. The document states "The Protectors have been tested and found in compliance with applicable requirements and standards specifications," but does not detail what tests, how many samples, or where the data originated from.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is entirely absent. The submission is based on demonstrating substantial equivalence through material and design comparisons and general performance testing (details not provided), not an expert-driven ground truth assessment.

4. Adjudication method for the test set

Not applicable/Not specified. There's no mention of a formal adjudication process for test results in this 510(k) summary.

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

This is not an AI/software device. No MRMC comparative effectiveness study was conducted or is relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of expert-derived ground truth. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices. The new devices are deemed "substantially equivalent" if they meet the same functional and material characteristics and do not raise new safety or effectiveness concerns.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. (See answer for #8).

Study that proves the device meets the acceptance criteria:

The document refers to a general "Discussion of performance testing" stating: "The Protectors have been tested and found in compliance with applicable requirements and standards specifications."

This is a high-level statement indicating that the device has undergone testing, but the 510(k) summary does not provide details of a specific study or its results to quantitatively demonstrate compliance with acceptance criteria. The core approval mechanism here is demonstration of substantial equivalence to predicate devices, not a novel performance study against specific acceptance metrics. The FDA's letter confirms this, stating, "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."

Summary

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

ATTACHMENT 5

KOGOGZA 1 of 3

510(K) SUMMARY

Mar 2 3 2009

Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the Carmel Pharma ab summary for the Protector P14, P21, P28 and P50 included in: PhaSeal® - A Closed System Drug Transfer Device for Preparation and Administration of Parenteral Drugs

SUBMITTER'S NAME:	Carmel Pharma ab
ADDRESS:	Box 5352SE 402 28 GoteborgSweden

CONTACT PERSON:	Kjell Andreasson
TELEPHONE NUMBER:	+46 31 7030400
FAX NUMBER:	+46 31 7030404
DATE OF SUBMISSION:	February 20, 2009

Identification of device 1.

Proprietary Name: Common Name: Classification Status: Product code:

PhaSeal Protector I.V. Fluid Transfer Set Class II per 21 CFR 880.5440 rHI

2. Equivalent devices

Protector P14, P21 and P50 cleared in K001368

3. Description of the Device

4. Intended use

Drug Vial Adapter for closed reconstitution of parenteral drugs.

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

K090634

2 of 3

5. Technological characteristics, comparison to predicate device.

Comparison table

Protector 14

Subject	Modified P14	Predicate P14, K001368	Equivalent
Intended use	Drug Vial Adapter for closedreconstitusion of parenteraldrugs.	Drug Vial Adapter for closedreconstitusion of parenteraldrugs.	Yes
Material	Polypropylene	Polypropylene	Yes
Spike	Stainless steel	Stainless steel	Yes
Drug vial size	Ø 13 mm	Ø 13 mm	Yes
Expansionchamber	20 ml	20 ml	Yes
Sterilizationmethod	EtO	EtO	Yes

Protector 21

Subject	Modified P21	Predicate P21, K001368	Equivalent
Intended use	Drug Vial Adapter for closed reconstitution of parenteral drugs.	Drug Vial Adapter for closed reconstitution of parenteral drugs.	Yes
Material	Polypropylene	Polypropylene	Yes
Spike	Stainless steel	Stainless steel	Yes
Drug vial size	Ø 20 mm	Ø 20 mm	Yes
Expansion chamber	20 ml	20 ml	Yes
Sterilization method	EtO	EtO	Yes

Protector 28

Subject	Modified P28	Predicate P50, K001368	Equivalent
Intended use	Drug Vial Adapter for closedreconstitution of parenteraldrugs.	Drug Vial Adapter for closedreconstitution of parenteraldrugs.	Yes
Material	Polypropylene	Polypropylene	Yes
Spike	Plastic	Stainless steel	No
Drug vial size	Ø 28 mm	Ø 28 mm	Yes
Expansionchamber	50 ml	50 ml	Yes
Sterilizationmethod	EtO	EtO	Yes

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

Protector 50
Subject	Modified P50	Predicate P50, K001368	Equivalent
Intended use	Drug Vial Adapter for closed reconstitution of parenteral drugs.	Drug Vial Adapter for closed reconstitution of parenteral drugs.	Yes
Material	Polypropylene	Polypropylene	Yes
Spike	Stainless steel	Stainless steel	Yes
Drug vial size	Ø 20 mm	Ø 20 mm	Yes
Expansion chamber	50 ml	50 ml	Yes
Sterilization method	EtO	EtO	Yes

6. Discussion of performance testing.

The Protectors have been tested and found in compliance with applicable requirements and standards specifications.

7. Conclusion

Based on comparison to the predicate device, we come to the conclusion that the Protectors P14, P21, P28 and P50 included in the PhaSeal System, are substantially equivalent to previously cleared predicate devices and presents no new concerns about safety and effectiveness.

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

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

MAR 2 & 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kjell Andreasson President Quality Assurance and Regulatory Affairs Carmel Pharma AB Box 5352 SE 402 28 Goteborg SWEDEN

Re: K090634

Trade/Device Name: Protector P14, P21, P28 and P50 Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: February 20, 2009 Received: March 9, 2009

Dear Mr. Andreasson:

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.

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

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sattie J. Michael Ows.

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Attachment 1

Indications for Use Statement

510(k) Number (if known)
Device Name	Protector P14, P21, P28 and P50
Indications for Use	The indication for use is reconstitution and transfer of drug solutions from one container to another while minimizing exposure to potentially hazardous drugs aerosols and spills that can occur during the reconstitution, administration and disposal process.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Yes
(Per 21 CFR 801. 109)
OR
Over-The-Counter Use: No

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

Page

Page 1 of 1

510(k) Number: K090634

Regulation Number and Section

§ 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.