(133 days)
Arrow Surgical Drapes are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
Arrow Surgical Drapes are sterile, disposable patient coverings for use in surgical procedures. They are composed of one or more of the following materials: Barrier, Absorbent, and Repellant materials. They may incorporate one or more fenestration openings for surgical site access and can also include medical grade patient fixation adhesive.
The provided document is a 510(k) summary for a surgical drape, which is a medical device. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device through performance testing, rather than clinical studies involving humans or AI algorithms. Therefore, many of the requested categories are not applicable to the information contained within this 510(k) summary.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists performance tests. While it specifies the types of tests performed, it does not provide explicit numerical acceptance criteria for these tests nor does it report the specific numerical results obtained for the Arrow Surgical Drape. It broadly states that the results "demonstrate that Arrow's Surgical Drapes are safe, effective and perform favorably when compared to the predicate drapes."
| Performance Test | Acceptance Criteria | Reported Device Performance |
|-----------------------------------------------------------|------------------------------------------------------------|
| Resistance to Liquid Penetration (Synthetic Blood) | "perform favorably when compared to the predicate drapes" |
| Resistance to Liquid Penetration (Hydrostatic Pressure) | "perform favorably when compared to the predicate drapes" |
| Spray Impact | "perform favorably when compared to the predicate drapes" |
| Linting - Gelbo Flex Test | "perform favorably when compared to the predicate drapes" |
| Tear Resistance | "perform favorably when compared to the predicate drapes" |
| Puncture Penetration | "perform favorably when compared to the predicate drapes" |
| Tensile Grab | "perform favorably when compared to the predicate drapes" |
| Flammability | "perform favorably when compared to the predicate drapes" |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the sample size for the "bench tests."
- Data Provenance: The tests are "bench tests" performed to demonstrate substantial equivalence against predicate devices. The country of origin of the data is not specified, but it would typically be conducted by or for the submitter (ARROW International, Inc. based in Reading, PA, USA). The study is non-clinical performance data, not a human study, so terms like "retrospective" or "prospective" are not applicable in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- N/A. This is a physical product (surgical drape) and the evaluation is based on non-clinical performance testing (bench tests) against recognized standards (AAMI, ASTM, ISO, AATCC, CFR). There is no "ground truth" established by human experts in the context of diagnostic accuracy, as is typical for AI device evaluations.
4. Adjudication Method for the Test Set:
- N/A. As mentioned above, there are no human readers or expert consensus required for these physical and material property tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is not an AI device or a diagnostic imaging device. It's a surgical drape, and its effectiveness is determined through physical performance tests, not through human reader interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- N/A. This is not an algorithm or AI device.
7. Type of Ground Truth Used:
- The "ground truth" in this context refers to the defined standards and methodologies for evaluating physical and material properties (e.g., AAMI PB70, ASTM F 1670, ISO 9073-10). The performance of the device is measured against these established standards and then compared to the performance of predicate devices.
- The document explicitly states: "The results of the bench tests demonstrate that Arrow's Surgical Drapes are safe, effective and perform favorably when compared to the predicate drapes." This comparison to predicate devices acts as a form of "ground truth" for substantial equivalence.
8. Sample Size for the Training Set:
- N/A. This device does not involve machine learning or AI, so there is no training set.
9. How the Ground Truth for the Training Set Was Established:
- N/A. As there is no training set, this question is not applicable.
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K07/491
007 10 2007
:
510 (k) Summary
| Submitter: | ARROW International, Inc.2400 Bernville RoadReading, PA 19605-9607 USA |
|---|---|
| Contact person: | Karl NittingerRegulatory Affairs SpecialistPhone: 610-378-0131, ext. 3405Fax: 610-478-3128Email: karl.nittinger@arrowintl.com |
| Date summary prepared: | May 14, 2007 |
| Device trade name: | Surgical Drape(21 CFR 878.4370, Product Code KKX) |
| Device common name: | Drape |
| Device classification name: | Surgical drape and drape accessories. |
| Legally marketed devices towhich the device issubstantially equivalent: | Medline Industries, Inc. Surgical Drape (K032666) andPacon Manufacturing Corp. Surgical Drape (K850960) |
| Description of the device: | Arrow Surgical Drapes are sterile, disposable patientcoverings for use in surgical procedures. They arecomposed of one or more of the following materials:Barrier, Absorbent, and Repellant materials. They mayincorporate one or more fenestration openings for surgicalsite access and can also include medical grade patientfixation adhesive. |
| Indications for use: | Arrow Surgical Drapes are intended to be used as aprotective patient covering, such as to isolate a site ofsurgical incision from microbial and other contamination. |
| Technologicalcharacteristics: | The proposed surgical drapes have the sametechnological design characteristics as the predicatedevices. |
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| Performance tests: | The following tests were performed to demonstrate substantial equivalence: |
|---|---|
| Resistance to Liquid Penetration (Synthetic Blood): [AAMI PB70:2003 (ASTM F 1670)]Resistance to Liquid Penetration (Hydrostatic Pressure): [AAMI PB70:2003 (AATCC 127)]Spray Impact: [AAMI PB70:2003 (AATCC 42)]Linting - Gelbo Flex Test: [ISO 9073-10:2004]Tear Resistance: [ASTM F 5733]Puncture Penetration: [ASTM F 1342]Tensile Grab: [ASTM D 5034]Flammability: [16 CFR Part 1610] | |
| Assessment of non-clinical performance data: | The results of the bench tests demonstrate that Arrow's Surgical Drapes are safe, effective and perform favorably when compared to the predicate drapes. |
| Summary | Arrow International's Surgical Drapes have the same intended use as the predicate device. Based on the assessment of non-clinical performance data and the technological characteristic comparison, Arrow's Surgical Drapes are substantially equivalent to the legally marketed predicate devices. |
K071491and the comments of the comments of the comments of the comments of
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Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is depicted as a triple-stranded design, resembling a bird in flight. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
OCT 1 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jeffrey D. Ravel Senior Regulatory Affairs Manager ARROW International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605-9607
Re: K071491
Trade/Device Name: Arrow Surgical Drape Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: September 27, 2007 Received: September 28, 2007
Dear Mr.Ravel:
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. Ravel
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) 594-4618. 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 yours,
Chiu Lin, 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 Statement
510(k) Number: K071491
Device Name: See attached list of product names
Indication For Use: Arrow Surgical Drapes are intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use ____________ (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K071491
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Attachment 1: Drape Device Names subject to this submission
| Drape Name | Drape ProductNumber | Size |
|---|---|---|
| Arrow Surgical DrapeClear Non-absorbable drape withFenestration | D-60004-001 | 24 in x 30 in |
| Arrow Surgical DrapeNon-absorbable drape | K-05600-035 | 12 in x 24 in |
| Arrow Surgical DrapeNon-absorbable drape withFenestration | D-05000-001 | 18 in x 26 in |
| Arrow Surgical DrapeAbsorbable drape withFenestration | K-05501-003 | 24 in x 30 in |
| Arrow Surgical DrapeAbsorbable drape withFenestration | D-05600-003 | 24 in x 36 in |
| Arrow Surgical DrapeAbsorbable drape with MultipleFenestrations | D-45703-008 | 78 in x 99 in |
| Arrow Surgical DrapeAbsorbable drape with Clear Non-Absorbable Fenestrated Window | D-45703-009 | 68 in x 110 in |
| Arrow Surgical DrapeAbsorbable drape with Clear Non-Absorbable Fenestrated Windowand Tear Line. Breathable in non-critical areas. | D-45703-013 | 54 in x 96 in |
| Arrow Surgical DrapeClear Non-absorbent Drape withAbsorbent Edging, Fenestrationand Tear Line | K-12703-001 | 21 in x 36 in |
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§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.