(247 days)
Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System is indicated for the post-operative collection of blood from an orthopedic surgerv patient's wounds and body cavities, filtration of that blood, and reinfusion of the blood into the same patient. Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System significantly reduces lipids, leucocytes, and C3a from the blood before reinfusing it.
The DONOR. HemoVac, Orthofusor, Solocotrans, and ConstaVac are intended to be use to collect, filter, and reinfuse blood lost by the patient due to surgery.
The provided text describes a medical device called "PALL's DONOR® Pre-evacuated Post-Operative Autologous Blood Transfusion System" and its performance data. However, the text does not contain detailed acceptance criteria or a comprehensive study description that directly matches all the requested information for analyzing an AI/ML device.
It's important to note that this document is a 510(k) summary for a traditional medical device (an autotransfusion system), not an AI/ML diagnostic tool. Therefore, many of the requested fields, such as "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "training set size," and "ground truth for the training set" are not applicable or not provided in the context of this device's regulatory submission.
The "Performance Data" section mentions "Bench data" which substantiates claims, but it does not detail the methodology, sample sizes, or a formal study comparing performance against acceptance criteria in the way an AI/ML device would be evaluated.
Given this context, here's an attempt to answer your questions based only on the provided text, while acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the claims made and the compliance with a standard. The reported performance is the "reduction" of certain components. Specific numerical thresholds for "significant reduction" are not provided in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ANSI/AAMI/AT-6 (1991) | Found to comply with ANSI/AAMI/AT-6 (1991) |
| Significant reduction of lipids | Significantly reduces lipids (bench data substantiates) |
| Significant reduction of leukocytes | Significantly reduces leukocytes (bench data substantiates) |
| Significant reduction of C3a | Significantly reduces C3a (bench data substantiates) |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document only mentions "Bench data" without detailing the number of samples or experimental runs.
- Data provenance: Not specified. As "Bench data," it implies laboratory testing, but the country of origin or whether it was retrospective/prospective is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. For this type of device (autotransfusion system), the "ground truth" would likely be based on objective analytical measurements (e.g., laboratory assays for lipids, leukocytes, C3a) rather than expert consensus on images or clinical assessments.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not specified. Adjudication methods are typically used for expert reviews in diagnostic studies, which is not the case here.
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
Not applicable. This is not an AI/ML diagnostic device, and thus no MRMC study involving human readers with/without AI assistance would have been conducted or is reported.
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. Its performance is inherent to its design and function. The "bench data" would represent the "standalone" performance of the device in a laboratory setting.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document mentions "Bench data substantiates each of these claims." This implies that the ground truth for reduction claims (lipids, leukocytes, C3a) would be established through objective laboratory analytical methods (chemical assays, cell counts, immunological assays, etc.) that measure the levels of these components before and after filtration by the device. It would not be expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, this question is not relevant.
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Attachment 7
510(k) SUMMARY
PALL's DONOR® Pre-evacuated Post-Operative Autologous Blood Transfusion System
Submitter's Name, Address, Telephone Number, Contact Personand Date Prepared
Pall Medical 2200 Northern Boulevard East Hills, NY 11548 Phone: 516-484-5400 516-801-9059 Fax:
Contact Person: Leonard S. Berman. Ph.D.
Date Prepared: June 28,2002]
Name of Device
Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System
Common or Usual Name: Autotransfusor
Classification Name: Autotransfusion Apparatus
Predicate Devices:
- Zimmer Hemovac ●
- Gish Biomedical, Inc.'s Orthofusor Wound Drainage/Autotransfusion System ●
- Richards' Solocotrans .
- Stryker Surgical's CBC-ConstaVac® ●
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Intended Use / Indications for Use
The DONOR. HemoVac, Orthofusor, Solocotrans, and ConstaVac are intended to be use to collect, filter, and reinfuse blood lost by the patient due to surgery. They are indicated for the post-operative collection of blood from an orthopedic surgery patient's wounds and body cavities, filtration of that blood, and reinfusion of the same patient. Thus, the DONOR has the same intended use and general indications as its predicate devices.
In addition, The DONOR significantly reduces lipids, leucocytes, and C3a from the blood before reinfusing it. The 510(k) notice includes bench data that substantiates each of these claims.
Performance Data
The Donor was tested in accordance with ANSVAAMI/AT-6 (1991) and found to comply with that standard. Bench data substantiates the DONOR's leukocyte, lipid, and C3a reduction claims.
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MAR 0 7 2003
Pall Corporation c/o Leonard S. Berman, Ph.D. Director of Scientific Affairs 2200 Northern Boulevard East Hills, NY 11548
Re: K022167
Trade Name: Pall Donor® Pre-evacuated Post-Operative Autologous Blood Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II (two) Product Code: CAC Dated: December 15, 2002 Received: December 17, 2002
Dear Dr. Berman:
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. Iisting 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 - Leonard S. Berman, Ph.D.
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) 594-4646. 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) you may obtain. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
M.A.B. D. Zakeri, M.D.
Bram D. Zuckerman. M.D. Director Division of Cardiovascualr Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 8
Indications for Use Statement
510(k) Number (if known):
Medical
Device Name: Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System
Indications for Use: Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System is indicated for the post-operative collection of blood from an orthopedic surgerv patient's wounds and body cavities, filtration of that blood, and reinfusion of the blood into the same patient. Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System significantly reduces lipids, leucocytes, and C3a from the blood before reinfusing it.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number K022167
Prescription Use
(Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).