(146 days)
Reprocessed Pulse Oximeter Sensors are used when continuous external monitoring of arterial oxygen saturation and pulse rate is required.
The subject devices are reprocessed pulse oximeter sensors model numbers Max-A and Max-N Pulse Oximeter Sensors originally manufactured by Nellcor.
The reprocessed pulse oximeter sensor is an electro-optical sensor that uses an optical means to determine the light absorption of functional arterial hemoglobin. The sensor contains three optical components: two light emitting diodes (LED's) that serve as light sources, and one photodiode, that acts as a light receiver. The oximeter sensor is positioned so that the LED's and photodiode oppose one another across the tissue. The sensor is connected via cable to a pulse oximeter, which provides continuous non-invasive, self-calibrated measurements of both oxygen saturation of functional hemoglobin and pulse rate. Please note that this submission only pertains to the sensor. It does not pertain to the pulse oximeter or connecting cable.
The provided document is a 510(k) summary for SterilMed, Inc.'s "Reprocessed Pulse Oximeter Sensors." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed de novo clinical study with specific acceptance criteria and performance data as would be typically found for novel AI/ML-driven medical devices.
Therefore, many of the requested categories regarding acceptance criteria, study design, ground truth establishment, and effect sizes cannot be directly extracted from this document because it describes a reprocessed medical device, not a new device with novel performance claims requiring extensive clinical outcome studies in the same way.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics commonly seen in device evaluation for AI/ML. Instead, the "acceptance criteria" are based on demonstrating substantial equivalence to a predicate device. The performance is reported in terms of functional and characteristic equivalence.
| Acceptance Criteria Category | Specific Criteria (Implicitly met for substantial equivalence) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Primary Criterion: Substantial Equivalence to Predicate Device (K012677) | The reprocessed device must be substantially equivalent to the predicate reprocessed pulse oximeter sensors across several key characteristics. | "The subject reprocessed pulse oximeter sensors are substantially equivalent to the predicate reprocessed pulse oximeter sensors. This conclusion is based upon the fact that this device is substantially equivalent to the predicate device in terms of functional design, indications for use, principles of operation and test performance characteristics." |
| Specific Equivalence Points | - Same indicated use- Same operating principle- Same basic design- Same technical characteristics- Same clinical performance characteristics- Same manufacturing environment- Same sterilization process- Same packaging configurations | The document explicitly states that the subject reprocessed Pulse Oximeter Sensors have these similarities to the predicate device. For "clinical performance characteristics" and "test performance characteristics," it implies that the reprocessed device performs comparably to the predicate device, but specific metrics are not provided in this summary. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a "test set" in the context of an AI/ML algorithm evaluation. The evaluation is based on demonstrating substantial equivalence through comparison of design, manufacturing, and general performance characteristics of the reprocessed device to the predicate device. There is no mention of a specific sample size for a clinical test set or data provenance for that kind of study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI/ML device requiring expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the typical sense for AI/ML. The "ground truth" for the reprocessed device's acceptability is essentially its demonstrated equivalence in functional, technical, and assumed clinical performance to an already legally marketed and accepted predicate device. Performance is likely validated through engineering and bench testing, confirming that the reprocessed device continues to meet the specifications and performance of the original and predicate reprocessed devices.
8. The sample size for the training set
Not applicable. This device does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable.
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SterilMed, Inc. Special 510(k)
SEP 2 3 2004
Reprocessed Pulse Oximeter Sensors
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Appendix F
510(k) Summary
| Submitter: | SterilMed, Inc.11400 73rd Ave. NMinneapolis, MN 55369ERN: 2134070 |
|---|---|
| Contact Person: | Dr. Bruce LesterVP Research and DevelpomentSterilMed, Inc.11400 73rd Avenue NorthMinneapolis, MN 55369Phone: (888) 856-4870Fax: (763) 488-3350 |
| Date Prepared: | April 26, 2004 |
| Trade Name: | Reprocessed Pulse Oximeter Sensors |
| Classification Nameand Number: | 21 CFR 870.2700 |
| Product Code: | NLF |
| Predicate DeviceName and 510(k)Number | Reprocessed Pulse Oximeter SensorsK012677 |
| Device Description: | DEVICE DESCRIPTIONThe subject devices are reprocessed pulse oximeter sensorsmodel numbers Max-A and Max-N Pulse Oximeter Sensorsoriginally manufactured by Nellcor.The reprocessed pulse oximeter sensor is an electro-opticalsensor that uses an optical means to determine the lightabsorption of functional arterial hemoglobin. The sensorcontains three optical components: two light emitting diodes(LED's) that serve as light sources, and one photodiode, thatacts as a light receiver. The oximeter sensor is positioned sothat the LED's and photodiode oppose one another across thetissue. The sensor is connected via cable to a pulse oximeter,which provides continuous non-invasive, self-calibratedmeasurements of both oxygen saturation of functionalhemoglobin and pulse rate. Please note that this submissiononly pertains to the sensor. It does not pertain to the pulseoximeter or connecting cable. |
| Intended Use: | Reprocessed Pulse Oximeter Sensors are used when continuousexternal monitoring of arterial oxygen saturation and pulse rateis required. |
| Statement ofTechnologicalComparison | The subject reprocessed Pulse Oximeter Sensors have thefollowing similarities to the Reprocessed Pulse OximeterSensor which previously received 510(k) clearance:The same indicated use; The same operating principle; The same basic design; The same technical characteristics; The same clinical performance characteristics; The same manufacturing environment; The same sterilization process; and The same packaging configurations. In summary, the subject device described in this submission is,in the opinion of SterilMed, substantially equivalent to thepredicate device. |
| Conclusion: | The subject reprocessed pulse oximeter sensors are substantiallyequivalent to the predicate reprocessed pulse oximeter sensors.This conclusion is based upon the fact that this device issubstantially equivalent to the predicate device in terms offunctional design, indications for use, principles of operationand test performance characteristics. |
04/26/04
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04/26/04
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized wing feathers.
SEP 2 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Bruce Lester Vice President Research & Development SterilMed, Incorporated 11400 73rd Avenue, North Minneapolis, Minnesota 55369
Re: K041127
Trade/Device Name: Modification To: Reprocessed Pulse Oximeter Sensors Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: July 27, 2004 Received: July 29, 2004
Dear Dr. Lester:
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 - Dr. Lester
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) 594-4613. 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 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 vours.
Susan Russo
fa Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Reprocessed Pulse Oximeter Sensors
Steri Med, Inc. Special 510(k)
Appendix B
Indications for Use Statement
| 510(k) Number (if known) | TBD |
|---|---|
| Device Name | Reprocessed Pulse Oximeter Sensors |
| Indications for Use | Reprocessed Pulse Oximeter Sensors are used when continuous external monitoring of arterial oxygen saturation and pulse rate is required. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||
|---|---|---|---|
| Prescription Use ✓(Per 21 CFR 801. 109) | OR | Over-The-Counter Use _____ | |
| (Division Sign-Off)Division of Anesthesiology, General Hospital,Infection Control, Dental Devices | |||
| 510(k) Number: | K041127 |
Appendix B, Page 1
Confidential SterilMed Inc. Snecial S10/k) for Renrocessed Pulse Oximeter Sensors
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).