(143 days)
Not Found
No
The summary describes a device that regulates CO2 flow and pressure based on clinician control, similar to existing air pumps. There is no mention of AI, ML, image processing, or data-driven decision-making.
No
The device is used for distention (diagnostic imaging) rather than treatment.
No
Explanation: The device is described as an insufflator designed to use CO2 as a distention media in the gastrointestinal tract during endoscopy. Its function is to facilitate the endoscopic procedure by distending the target area, not to diagnose a condition.
No
The device description explicitly states it is an "insufflator" and regulates CO2 flow and pressure, which are hardware functions. The performance studies also include testing for electrical safety, EMC, and biocompatibility of materials, all indicative of a physical device. While software is mentioned as being tested, it is in the context of modifications to a physical device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to use CO2 as a distention media in the gastrointestinal tract during endoscopy. This is a procedure performed directly on a patient's body.
- Device Description: The device regulates the flow and pressure of CO2 for insufflation within the gastrointestinal tract. This is a physical intervention, not a test performed on samples outside the body.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are typically used to diagnose diseases or conditions by examining these types of samples.
The device is clearly intended for use in vivo (within a living organism) to facilitate an endoscopic procedure, which is a medical intervention, not a diagnostic test performed in vitro (outside a living organism).
N/A
Intended Use / Indications for Use
The Bracco Diagnostics, Inc. (BDI) CO2MPACT ENDOSCOPIC INSUFFLATOR™ is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
The BDI CO2MPACT ENDOSCOPIC INSUFFLATOR™ allows the physician to modulate and control the CO2 to the patient in an identical manner to that being done currently with room air which is supplied by an air pump in the light source of the endoscopic equipment.
Product codes
FCX
Device Description
The Bracco Diagnostics, Inc. (BDI), CO2MPACT ENDOSCOPIC INSUFFLATOR™ (CO2MPACT) is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. The BDI CO2MPACT regulates CO2 flow rate and pressure during the insufflation process.
The BDI CO2MPACT allows the physician to modulate and control the CO2 to the patient in an identical manner to that being done currently with room air which is supplied by an pump in the light source of the endoscopic equipment.
Consistent with the predicate devices, the BDI CO2MPACT is used to administer CO2 to the patient for distention purposes. For this application, the actual displacement of CO2 to the patient through the endoscope is controlled by the clinician modulating an "air-water" valve on the endoscope. The BDI CO2MPACT only provides source pressure and flow to the endoscope in a similar manner to the predicates BDI CO2Efficient Endoscopic Insufflator (K053008) and Olympus UCR Endoscopic CO2 Regulation Unit (K081173), or the internal air pump included within the endoscope light source.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing: The BDI CO2MPACT was tested for performance in accordance with internal requirements. Test results indicated that the BDI CO2MPACT complies with its predetermined specification and with the applicable Standards.
Biocompatibility Verification: Patient contact materials within the BDI CO2MPACT and the tubing set was verified for performance in accordance with:
• ISO 10993-1: 2009, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
Verification results indicated that the materials comply with predetermined specifications.
Software Testing: Software device modifications made to the BDI CO2MPACT were designed and developed according to a robust software development process, and were rigorously verified and validated. Software information is provided in accordance with:
• FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05;
• FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99;
• FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02; and
• IEC 60601-1-4: 2000, Medical electrical equipment – Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems.
Test results indicate that the BDI CO2MPACT complies with its predetermined specification.
Electrical Safety Testing: The BDI CO2MPACT was tested for patient safety in accordance with:
• IEC 60601-1: 1988, Am1: 1991, Am2: 1995, Medical Electrical Equipment, Part 1: General Requirements for Safety; and
• UL 60601-1: 2006, Medical Electrical Equipment, Part 1: Particular Requirements for Safety.
Test results indicated that the BDI CO2MPACT complies with applicable Standards.
Electromagnetic Compatibility Testing: The BDI CO2MPACT was tested for EMC in accordance with:
• IEC 60601-1-2: 2007, Medical Electrical Equipment, Part 1: Particular Requirements for Safety - Collateral Standard: Electromagnetic Compatibility-Requirements and Tests
Test results indicated that the BDI CO2MPACT complies with applicable Standards.
Performance Testing - Bench: The BDI CO2MPACT was tested for performance in accordance with internal requirements. Test results indicated that the BDI CO2MPACT complies with applicable Standards.
Conclusion: Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications made to the BDI CO2MPACT. The results of these activities demonstrate that the BDI CO2MPACT is safe and effective when used in accordance with its intended use and labeling. Therefore, the BDI CO2MPACT is considered substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Page 1 of 4
NOV - 3 2011
. . . . .
| Submission Date: | 06 June 2011 | ||
|---|---|---|---|
| Submitter: | Bracco Diagnostics, Inc. | ||
| 532 Broadhollow Road, Suite 126 | |||
| Melville, NY 11747 USA | |||
| Submitter and | |||
| Official Contact: | Ms. Tracey Alexander | ||
| Director Regulatory Affairs | |||
| +1 (609) 524-2865 | |||
| +1 (631)-847-3904 (fax) | |||
| tracey.alexander@diag.bracco.com | |||
| Trade Name: | Bracco Diagnostics, Inc. CO2MPACT ENDOSCOPIC | ||
| INSUFFLATOR™ | |||
| Common Name: | CO2 Insufflator | ||
| Classification Name: | Endoscope and accessories | ||
| Classification | |||
| Regulation: | 21 CFR §876.1500 | ||
| Product Code: | FCX | ||
| Substantially | |||
| Equivalent Devices: | New BDI Model | Predicate | |
| 510(k) | |||
| Number | Predicate | ||
| Manufacturer / Model | |||
| Bracco Diagnostics, Inc. | |||
| CO2MPACT ENDOSCOPIC | |||
| INSUFFLATOR™ | K053008 | E-Z-EM, Inc. (now BDI) | |
| / CO2Efficient | |||
| Endoscopic Insufflator | |||
| K081173 | Olympus Medical | ||
| Systems, Corp. / UCR | |||
| Endoscopic CO2 | |||
| Regulation Unit |
i :
. . . .
.
,
.
.
1
K 111648
Page 2 of 4
The Bracco Diagnostics, Inc. (BDI), CO2MPACT ENDOSCOPIC Device Description: INSUFFLATOR™ (CO2MPACT) is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. The BDI CO2MPACT regulates CO2 flow rate and pressure during the insufflation process.
The BDI CO2MPACT allows the physician to modulate and control the CO2 to the patient in an identical manner to that being done currently with room air which is supplied by an air pump in the light source of the endoscopic equipment.
Consistent with the predicate devices, the BDI CO2MPACT is used to administer CO2 to the patient for distention purposes. For this application, the actual displacement of CO2 to the patient through the endoscope is controlled by the clinician modulating an "air-water" valve on the endoscope. The BDI CO2MPACT only provides source pressure and flow to the endoscope in a similar manner to the predicates BDI CO2Efficient Endoscopic Insufflator (K053008) and Olympus UCR Endoscopic CO2 Regulation Unit (K081173), or the internal air pump included within the endoscope light source.
Intended Use:
The Bracco Diagnostics, Inc. (BDI) CO2MPACT ENDOSCOPIC INSUFFLATOR™ is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
The BDI CO2MPACT ENDOSCOPIC INSUFFLATOR™ allows the physician to modulate and control the CO2 to the patient in an identical manner to that being done currently with room air which is supplied by an air pump in the light source of the endoscopic equipment.
Technology Comparison: The BDI CO2MPACT employs the same technological characteristics as the predicate devices.
2
K/// 648
page 3 of 4
Summary of Performance Testing:
! :
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------:
| Performance Testing | The BDI CO2MPACT was tested for performance in accordance with
internal requirements. | | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | Test results indicated that the BDI CO2MPACT complies with its
predetermined specification and with the applicable Standards. | | |
| Biocompatibility
Verification | Patient contact materials within the BDI CO2MPACT and the tubing
set was verified for performance in accordance with: | | |
| | • ISO 10993-1: 2009, Biological evaluation of medical devices – Part
1: Evaluation and testing within a risk management process. | | |
| | Verification results indicated that the materials comply with
predetermined specifications. | | |
| Software Testing | Software device modifications made to the BDI CO2MPACT were
designed and developed according to a robust software development
process, and were rigorously verified and validated. | | |
| | Software information is provided in accordance with: | | |
| | • FDA guidance: The content of premarket submissions for software
contained in medical devices, 11 May 05; | | |
| | • FDA guidance: Off-the-shelf software use in medical devices, 09
Sep 99; | | |
| | • FDA guidance: General principles of software validation; Final
guidance for industry and FDA staff, 11 Jan 02; and | | |
| | • IEC 60601-1-4: 2000, Medical electrical equipment – Part 1-4:
General requirements for safety - Collateral standard:
Programmable electrical medical systems. | | |
| | Test results indicate that the BDI CO2MPACT complies with its
predetermined specification. | | |
:
3
K 111648
Page 4 of 4
Special 510(k) Premarket Notification Bracco Diagnostics, Inc. CO2MPACT ENDOSCOPIC INSUFFLATOR™ 510(k) Summarv
Electrical Safety The BDI CO2MPACT was tested for patient safety in accordance with: Testing . IEC 60601-1: 1988, Am1: 1991, Am2: 1995, Medical Electrical Equipment, Part 1: General Requirements for Safety; and . UL 60601-1: 2006, Medical Electrical Equipment, Part 1: Particular Requirements for Safety. Test results indicated that the BDI CO2MPACT complies with applicable Standards. Electromagnetic The BDI CO2MPACT was tested for EMC in accordance with: Compatibility IEC 60601-1-2: 2007, Medical Electrical Equipment, Part 1: Part . Testing 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility-Requirements and Tests Test results indicated that the BDI CO2MPACT complies with applicable Standards. Performance Testing The BDI CO2MPACT was tested for performance in accordance with - Bench internal requirements. Test results indicated that the BDI CO2MPACT complies with applicable Standards. Conclusion Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications made to the BDI CO2MPACT. The results of these activities demonstrate that the BDI CO2MPACT is safe and effective when used in accordance with its intended use and labeling. Therefore, the BDI CO2MPACT is considered substantially equivalent to the predicate device.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Tracev Alexander Director Regulatory Affairs Bracco Diagnostics, Inc. 532 Broadhollow Road, Suite 126 MELVILLE NY 11747
NOV - 3 2011
Re: K111648
Trade/Device Name: Bracco Diagnostics, Inc. CO2MPACT ENDOSCOPIC INSUFFLATOR™ Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FCX Dated: October 14, 2011 Received: October 20, 2011
Dear Ms. Alexander:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting of medical device-related
5
adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hubert Lenoir MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
K/11448
510(k) Number (if known):
Device Name:
:
Indications for Use:
Bracco Diagnostics, Inc. CO2MPACT ENDOSCOPIC INSUFFLATOR™
The Bracco Diagnostics, Inc. (BDI) CO2MPACT ENDOSCOPIC INSUFFLATOR™ is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
The BDI CO2MPACT ENDOSCOPIC INSUFFLATOR™ allows the physician to modulate and control the CO2 to the patient in an identical manner to that being done currently with room air which is supplied by an air pump in the light source of the endoscopic equipment.
Over-The-Counter Use
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
(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)
Herbert Lehman
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K111648
Page 1 of 1