(100 days)
The AC-1 Adapter Cable with Masimo sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (measured by an SpO₂ sensor) for use with adult, pediatic, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
The AC-1 Adapter Cable is fully conpatible oximetry cable that allows the use of Masimo LNOP Sensors with Nellow and Nellcor compatible pulse oximeter monitors. The cable represents a design change to the Masino patient cables. The AC-1 Adapter Cable is similar in construction to the predicate device enabling the Masimo LNOP Sensors to be comected to Nelleor and Nellcor compatible pulse oximeter monitors.
This Masimo AC-1 Adapter Cable is a cable that connects Masimo LNOP sensors to Nellcor and Nellcor-compatible pulse oximeter monitors. The 510(k) summary doesn't outline acceptance criteria directly for the adapter cable itself but rather refers to the accuracy of the Masimo LNOP sensors when used with the AC-1 adapter cable. The study mentioned supports the substantial equivalence of this combination.
Here's a breakdown of the information requested based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance (AC-1 with Masimo LNOP Sensors) |
|---|---|
| SpO2 Accuracy for Adults, Pediatrics & Infants (70%-100% SaO2 Range) | Less than 2% SpO2 ARMS |
| SpO2 Accuracy for Neonates (70%-100% SaO2 Range) | Less than 3% ARMS |
Note: The acceptance criteria are "implied" because the document states the accuracy is "equivalent to those of the predicate devices" and then provides the accuracy values achieved. It doesn't explicitly state "Our acceptance criterion is an accuracy of X%."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The document mentions "adult oximetry sensors on human volunteers under induced hypoxic conditions." It does not specify the number of volunteers.
- Data Provenance: Prospective. The study involved "human volunteers under progressive induced hypoxia." Country of origin is not specified, but Masimo Corporation is based in Irvine, CA, USA.
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. The ground truth was established by a CO-Oximeter, not human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Ground truth was established by a CO-Oximeter.
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 device is a cable for a pulse oximeter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the performance listed directly reflects the accuracy of the Masimo LNOP sensors when used with the AC-1 Adapter Cable, measured against a CO-Oximeter. This is a standalone performance assessment of the device (or the device in combination with its intended sensor).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth was established by a CO-Oximeter measuring arterial hemoglobin oxygen from arterial blood samples. This is considered a gold standard for blood oxygen saturation measurement.
8. The sample size for the training set
Not applicable. This device is a passive cable and does not involve machine learning or training sets in the conventional sense.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image shows the logo for Masimo, along with their address and contact information. The address is 2852 Kelvin Avenue, Irvine, CA 92614. The phone number is 949-250-9688, and the fax number is 949-250-9686. There is also a number K033349 written on the top left of the image.
510(k) SUMMARY
JAN 2 8 2004
| Submitted by: | Masimo Corporation2852 Kelvin AveIrvine, CA 92614-5826(714) 250-9688FAX (714) 250-9686 |
|---|---|
| Company Contact: | James J. Cronin, Vice President, Regulatory Affairs/Quality Assurance |
| Date Summary Prepared: | October 17, 2003 |
| Trade Name | AC-1 Adapter Cable |
| Common Name | Cable, Transducer and Electrode |
| Classification Name and Product Code: | Cable, Transducer and Electrode (74DSA) (870.2900) |
| Substantially Equivalent Devices: | Masimo SET ® Radical Pulse Oximeter with SatShare ™ and LNOP ® series of Sensors andCables510(k) Number - K031330Nellcor N-395 Pulse Oximeter - K991823Nellcor N-200 Pulse Oximeter - K863784 |
Device Description
The AC-1 Adapter Cable is fully conpatible oximetry cable that allows the use of Masimo LNOP Sensors with Nellow and Nellcor compatible pulse oximeter monitors. The cable represents a design change to the Masino patient cables.
The AC-1 Adapter Cable is similar in construction to the predicate device enabling the Masimo LNOP Sensors to be comected to Nelleor and Nellcor compatible pulse oximeter monitors.
Intended Use
The AC -1 Adapter Cables used with Masimo LNOP Sensors are intended for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO3) and pulse rate (measured by an SpO2 sensor) for adult, pediatic, infant, and neonatal patients in hospitals, hospital-type facilitics, mobile, and home environments.
Technology Comparison
I'he AC-1 Adapter Cables used with Masimo LNOP Sensors are substantially equivalent in intended use, design, principles of operation, materials, and performance to predicate sensors and operate on identical principles of non-invasive optical assessment of tissue oxygenation using emitters and detectors.
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510(k) SUMMARY
The AC-1 Adapter Cable is designed, configured, and manufactured for full compatibility with Nellcor compatible The AC-1 Adapter cable is dongiled, comigated, and the constructed of similar materials and components of equivalent specifications as used in the predicate devices.
The accuracy of the AC-1 Adapter Cables used with Masimo LNOP Sensors is cquivalent to those of the prodicale devices.
Performance Testing
Environmental Testing
Applicable environmental testing per the Reviewers Guidance for Premarket Submissions - November 1993, i.e. electrical, mechanical and environmental were performed and all tests passed
Clinical Testing
Clinical studies were performed using the AC-1 Adapter Cables used with Masimo I.NOP Adult oximetry sensors on Challed studios were permined as a motion conditions who were subjected to a progressive induced lypoxia and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter. Clinical testing of the SPO2.COM Adult and Reusable sensors resulted in an accuracy of less than 2% SpO2 Arsss in the range of 70%-100% SaO2 for adults, pediatrics and infants and less than 3% ARMS for neonates.
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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 features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2004
Mr. James J. Cronin Vice President, Regulatory Affairs/Quality Assurance Masimo Corporation 2852 Kelvin Avenue Irvine, California 92614-5826
Re: K033349
Trade/Device Name: AC-1 Adapter Cable Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, DPZ Dated: January 21, 2004 Received: January 22, 2004
Dear Mr. Cronin:
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. James J. Cronin
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 3 issualled of a basedan in that your device with other requirements mean that FTA has made a decermination administered by other Federal agencies. of the Act of ally receral statutes and regalates. Including, but not limited to: registration You must comply with an the Hee Here (21 CFR Part 801); good manufacturing practice and ifsing (21 CFR Part 067), lacelity systems (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 612 requirements as set form in the quality bysteins (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) This letter will anow you to begin mationing of substantial equivalence of your device to a premiarket notification. The PDF intents 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), If you desire specific advice to: Jour de at (301) 594-4646. Also, please note the regulation in 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 may obtain other general micrinational and Consumer Assistance at its toll-free Division of Binastic of Binastic (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Clair Liu, Ph.D.
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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Indications for Use
K033349 510(k) Number (if known):
AC-1 Adapter Cable Device Name:
Indications For Use:
The AC-1 Adapter Cable with Masimo sensors are indicated for the continuous noninvasive monitoring of functional r no re a readion of arterial hemoglobin (SpO₂) and pulse rate (measured by an SpO₂ sensor) for use with adult, pediatic, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
Prescription Use __ X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (Per 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
S. Hinkle
Division of Anesthesiology, General Hospital,
510(k) Number: K633349
0027
§ 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).